tag:blogger.com,1999:blog-64462541681502273672024-02-06T19:13:46.018-08:00Onward Through the FogA practical resource for treating CFS/ME ... coping tips, specialists, books, articles, research, and advice on how to recover from this debilitating illness. #NotMyPresidentErica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comBlogger305125tag:blogger.com,1999:blog-6446254168150227367.post-78361297493314350762017-11-24T05:26:00.000-08:002017-11-24T05:26:57.787-08:00INIM ME/CFS Genes Study Is Recruiting!<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgB1I5chVuDNFD5VeYKs2xckh7lsl8RlWH1n0fqymkDbB9gHY9ZRP9_zgqrmTVt0JG8dF6pgmyic1_9tT3Q3DncCdL3bmhzOs6yidAacYnoVdUMJbxx2QFrapr98WKqQHvs-zcawfYd-rU/s1600/neuro-immune8.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="260" data-original-width="643" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgB1I5chVuDNFD5VeYKs2xckh7lsl8RlWH1n0fqymkDbB9gHY9ZRP9_zgqrmTVt0JG8dF6pgmyic1_9tT3Q3DncCdL3bmhzOs6yidAacYnoVdUMJbxx2QFrapr98WKqQHvs-zcawfYd-rU/s1600/neuro-immune8.jpg" /></a></div>
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<i><br /></i></div>
<i>From The Institute of Neuroimmune Medicine</i>:<br />
<br />
We are currently recruiting ME/CFS patients AND Healthy Controls for this completely web based study to create a one of a kind genetic database for individuals with ME/CFS. <br />
<br />
Participation for this study requires you to have a computer with internet access, an email account and your agreement to map your genes through the use of a publicly available genetic testing websites. If you agree to participate, you will provide us with your raw genetic data for us to compile in a one of a kind, ME/CFS Genetic Database. <br />
<br />
Besides providing us with your genetic data, participants will be completing online surveys at your own pace. As all communication is done via secure email server, NO travel is necessary and participation can be done in the comfort of your home!<br />
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<br /></div>
<div>
<i>Read more here</i>:<br />
<br />
<a href="http://www.nova.edu/nim/research/mecfs-genes.html" target="_blank">http://www.nova.edu/nim/research/mecfs-genes.html</a></div>
Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-70639752114874352322017-11-23T04:37:00.000-08:002017-11-23T04:45:11.083-08:00Telebriefing on NIH Research - November 28, 2017<div class="" data-block="true" data-editor="ed7of" data-offset-key="9gpe5-0-0">
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"We request your participation in a telebriefing about updates on NIH’s efforts to advance research on ME/CFS. The telebriefing will be held on November 28, 2017, 1:00 until 2:00 pm ET. If you will be calling from the U.S., please use the following dial-in information for the telebriefing.<br />
<br />
Dial-in: 877-951-7311<br />
<br />
Participant passcode: 8394694<br />
<br />
If you will be calling from another country, please see the attached chart for your country’s access information.<br />
<br />
Please remember to register at NIHME CFSWorkingG@ninds.nih.gov if you plan to participate in the call.<br />
<br />
Thank you in advance for your participation and we look forward to an engaging, thoughtful and productive conversation.<br />
<br />
Regards,<br />
<br />
The Trans-NIH ME/CFS Working Group"<br />
<br />
Dial in numbers:<br />
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THAILAND 001-800-1206-66639<br />
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TURKEY 00-800-151-0818<br />
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UNITED ARAB EMIRATES 8000-35702389<br />
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UNITED KINGDOM BIRMINGHAM: 44-121-210-9183 0808-238-9817<br />
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UNITED KINGDOM LEEDS: 44-113-301-0013 0808-238-9817<br />
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UNITED KINGDOM LONDON: 44-20-7950-1322 0808-238-9817<br />
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Restrictions may exist when accessing freephone/toll free numbers using a mobile telephone.<br />
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PASSCODE: 8394694</div>
Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-68195327535209575292016-11-08T07:31:00.000-08:002016-11-08T08:36:03.513-08:00TAKE ACTION! Denounce Dr. Shorter Speaking at the NIH<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXahiJlGLkB3vcr1AYtltlnMyE36hUsgr0A3LYuBNnbCHJiNW0KBTGVmuR8vrsdOMxlAaP26vF0x9C4DYPADgjOhH-9UmSI6ezqCjcZqVLQbMYZeYZ-IyUD5bTV7vh8TO41HeG23xHksU/s1600/heads+in+sand.png" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="201" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXahiJlGLkB3vcr1AYtltlnMyE36hUsgr0A3LYuBNnbCHJiNW0KBTGVmuR8vrsdOMxlAaP26vF0x9C4DYPADgjOhH-9UmSI6ezqCjcZqVLQbMYZeYZ-IyUD5bTV7vh8TO41HeG23xHksU/s400/heads+in+sand.png" width="400" /></a></div>
Professor Shorter's invitation to speak at the NIH is a travesty.<br />
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Would a prestigious national institution invite a Holocaust denier to speak about World World II, or a member of the KKK to speak about race relations?<br />
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<br /></div>
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We can't know what they were thinking when the NIH extended their invitation to Dr. Shorter, who is certainly no expert on any aspect of ME/CFS. But we do know that inviting a man who is so outspoken in his absolute denial of the disease reflects very poorly on the attitudes of the institution that recently pledged to take ME/CFS "very seriously."<br />
<br />
You can read more about Dr. Shorter's invitation as well as his disparagement of ME/CFS patients <a href="http://www.healthrising.org/forums/threads/nih-stumbles-asks-me-cfs-denier-to-speak-on-chronic-fatigue-syndrome.5052/">HERE</a>. </div>
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Dr. Shorter is scheduled to speak on November 9. Please send a letter to your representative today.<span style="color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"><span style="color: black; font-family: "times new roman"; font-size: small;"><br /></span></span><br />
<br />
________________________<br />
<br />
<i>I sent this little note to Dr. Collins:</i><br />
<i><br /></i>
To: collinsf@mail.nih.gov</div>
<div>
<br />
Dear Dr. Collins,<br />
<br />
I am sure you realize by now that the response to your invitation to have Dr. Shorter speak at the NIH has been less than positive.<br />
<br />
Dr. Shorter is a crank. He has no expertise in ME/CFS - of any kind - and has made a reputation for himself by making outrageous statements worthy of the National Enquirer. The fact that he has published a book on the subject does not qualify him to speak as an expert. (I have published two books of more merit than his, and yet I do not recall receiving an invitation from you.)<br />
<br />
In case you do not remember, you made a promise to take ME/CFS "very seriously." You asked the ME/CFS community to bear with you as you "ramped up" ME/CFS research. (We are still waiting for the ramping up.) Is being called "hysterics," "whiners," and "complainers" one of the things we must bear? Would you ask the same of patients with Parkinson's disease, Alzheimer's, or cancer?<br />
<br />
What you have done is let a fox into the hen house. You have also done irreparable harm to the good will you built by appearing to offer a helping hand to patients who have suffered the ravages of this disease, and then dashing our hopes with this crude gesture of contempt.<br />
<br />
Yours,<br />
<br />
Erica Verrillo, author, Chronic Fatigue Syndrome: A Treatment Guide<br />
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<i>From </i><a href="http://solvecfs.org/action-alert-denounce-dr-shorter-speaking-at-the-nih/">Solve ME/CFS Initiative</a><br />
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BREAKING NEWS: Last week, deeply troubling information was discovered on an archived National Institutes of Health (NIH) webpage. A lecture titled “Chronic Fatigue Syndrome in Historical Perspective” is scheduled for Wednesday, November 9, to be presented by the controversial and inflammatory history professor Edward Shorter, PhD.</div>
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A professor of psychiatry and history at the University of Toronto, Shorter is an outspoken skeptic about the biological nature of ME/CFS. He has referred to the disease as both a “psychodrama” and a “psychic epidemic” and called the findings of the Institute of Medicine’s report on ME/CFS last year “junk science.”</div>
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Read more about this announcement here: <a href="http://solvecfs.org/disparaged-speaker-to-present-at-nih-next-week/" style="color: #54632c; text-decoration: none;">http://solvecfs.org/disparaged-speaker-to-present-at-nih-next-week/</a>.</div>
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The Solve ME/CFS Initiative is formally protesting the inclusion of Dr. Shorter as a speaker and writing to the NIH to ask them to provide scientifically grounded balance.</div>
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Read SMCI’s letter here: <a href="http://solvecfs.org/wp-content/uploads/2016/11/SMCI-Letter-of-Protest-Dr-Shorter.pdf" style="color: #54632c; text-decoration: none;">http://solvecfs.org/wp-content/uploads/2016/11/SMCI-Letter-of-Protest-Dr-Shorter.pdf</a>.</div>
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We need your help in contacting your congressional representative ASAP to keep up the pressure on the NIH.</div>
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Follow these three easy steps below:</div>
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Step 1: Call your representative</h2>
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To find your U.S. House of Representatives member, visit <a href="http://www.house.gov/representatives/find/" style="color: #54632c; text-decoration: none;">http://www.house.gov/representatives/find/</a>.</div>
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Please note that this action is for REPRESENTATIVES ONLY, NOT SENATORS.</div>
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Please call the Washington DC office, not the district office, and ask to speak to the legislative assistant for health. If the legislative assistant is not available, you can ask to leave a message or immediately ask for the e-mail address of the legislative assistant to send him or her your request in writing.</div>
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Feel free to tell the legislative assistant your story, but remember to be very brief. Use the sample script below as a guide.</div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">My name is _________. I’m a constituent in <strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">{city}</strong>. I am calling with an urgent request for Representative <strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">{NAME}</strong> to contact the National Institutes of Health. The NIH has invited an inflammatory and controversial speaker, Dr. Shorter, who denies that ME/CFS is a physical disease. Between 1 to 2.5 million Americans like <strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">me [or my family member]</strong> who are afflicted with the horrific, disabling, and costly disease myalgic encephalomyelitis, also known as chronic fatigue syndrome or ME/CFS. ME/CFS has no known cause, cure, diagnostic test, or FDA-approved treatment, and it often leaves patients bedridden for decades. Please urge Representative <strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">{NAME}</strong> to support patients and voice their concern about this troubling speaker who calls <strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">me [or my family member] </strong>“delusional.” May I have your e-mail address to send you additional information?</em></div>
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If you do not receive an e-mail address for a particular staffer, ask for the general comment e-mail address.</div>
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Step 2: E-mail your representative</h2>
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After you speak to the staff person by phone, it is always helpful to follow up with an e-mail. Download a helpful ME/CFS <strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">issue </strong>fact sheet here (<a href="http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf" style="color: #54632c; text-decoration: none;">http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf</a>) to include with your e-mail. Feel free to personalize the e-mail below.</div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Dear Congress Member <span style="border: 0px; color: red; margin: 0px; padding: 0px; vertical-align: baseline;">[LAST NAME]</span>,</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">As a constituent and as a <span style="border: 0px; color: red; margin: 0px; padding: 0px; vertical-align: baseline;">(caregiver to / loved one of)</span> a patient with myalgic encephalomyelitis (ME), commonly known as chronic fatigue syndrome (CFS), I am bringing your attention to the immediate need for Congress to assist ME/CFS patients. In September, 55 bipartisan members of the House of Representatives joined together to write to NIH Director Francis Collins regarding ME/CFS. That letter was not enough, and we need your help now.</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">As you may know, ME/CFS is a complex disease with no known cause, treatment, diagnostic tool, nor cure. The CDC estimates that up to 2.5 million Americans suffer from ME/CFS, and patients have lower quality of life scores than those with lung cancer, stroke, and rheumatoid arthritis. According to the 2015 Institute of Medicine Report on ME/CFS, the disease costs the U.S. economy an estimated $17-$24 billion per year.</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">The National Institutes of Health (NIH) has not taken substantial action. When Director Collins responded to Congress, he wrote of an ME/CFS Interest group, a lecture series, and the promise of funding to come. Read more about Director Collins’s response here: <a href="http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf" style="color: #54632c; text-decoration: none;">http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf</a>.</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;"><strong style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">And the NIH continues to disregard the legitimate needs of ME/CFS patients</strong>. On Wednesday, November 9, the NIH’s clinical center is scheduled to host a lecture given by Dr. Edward Shorter, a historian at the University of Toronto and one of the most controversial and inflammatory figures to the ME/CFS patient community. This man, despite overwhelming scientific evidence, does not believe ME/CFS is an actual disease—instead calling it a “psychic epidemic” perpetrated by “moaning and groaning victims” who are “delusional.” Dr. Shorter has written pieces so disparaging of patients that they were removed from circulation by </em>Psychology Today<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">.</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">The NIH is clearly not prioritizing a solution to ME/CFS when they provide a forum for a speaker who demeans patients and denies scientific findings. I am asking you to please stand with patients who are very ill with this very REAL physiological disease, as verified by thousands of published scientific articles.</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Please contact NIH Director Francis Collins and ask him to</em></div>
<ul style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; margin: 0px; padding: 0px 0px 0px 2em; vertical-align: baseline;">
<li style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; line-height: 1.4; margin: 0.333em 0px; padding: 0px; vertical-align: baseline;"><em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Present scientifically grounded information to NIH researchers. If the NIH insists on including an inflammatory and controversial speaker who offers no scientific rigor, please balance this with an opposing expert such as Mary Dimmock, author of </em>30 Years of Disdain: How HHS and a Group of Psychiatrists Buried Myalgic Encephalomyelitis<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">.</em></li>
<li style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; line-height: 1.4; margin: 0.333em 0px; padding: 0px; vertical-align: baseline;"><em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Reaffirm the findings of the Institute of Medicine report that ME/CFS is a true physiological disease, not a psychological one.</em></li>
<li style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; line-height: 1.4; margin: 0.333em 0px; padding: 0px; vertical-align: baseline;"><em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Prioritize ME/CFS funding with substantial investment commensurate with the burden of this devastating disease.</em></li>
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<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Only continued oversight from you and your colleagues in Congress will induce the NIH to take the actions necessary to help patients.</em></div>
<div style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; font-family: "Arial Narrow", Arial, sans-serif; font-size: 16px; line-height: 1.4; margin-bottom: 1em; margin-top: 1em; padding: 0px; vertical-align: baseline;">
<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;">Very truly yours,</em></div>
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<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;"><span style="border: 0px; color: red; margin: 0px; padding: 0px; vertical-align: baseline;">(NAME)</span></em></div>
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Step 3: Let us know how it went</h2>
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E-mail our advocacy and engagement manager, Emily Taylor (<a href="mailto:etaylor@solvecfs.org" style="color: #54632c; text-decoration: none;">etaylor@solvecfs.org</a>), to let us know your member of Congress received the message.</div>
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Thank you for doing your part to advocate on behalf of all the patients who suffer with this disease.</div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-4904195214007674022016-11-04T10:29:00.000-07:002016-11-04T10:29:04.844-07:00Komaroff summary of 2016 IACFS/ME meeting<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOsalrp8M9GgTs5Nw8odag-xAyXGmowDDjPOKuk2ErqJfZaPjUIroU6fy9-kF_tJI-FIanR8Q6SF9IRC_N9pMDaSw0S7SsvhmAmymoqg5Uv3Z2TodOxOqlZm0skC-fbPDisvAdujGpYOw/s1600/Fort-Lauderdale-Westin.png" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="270" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOsalrp8M9GgTs5Nw8odag-xAyXGmowDDjPOKuk2ErqJfZaPjUIroU6fy9-kF_tJI-FIanR8Q6SF9IRC_N9pMDaSw0S7SsvhmAmymoqg5Uv3Z2TodOxOqlZm0skC-fbPDisvAdujGpYOw/s400/Fort-Lauderdale-Westin.png" width="400" /></a></div>
The IACFS/ME (International Association for CFS and ME) Conference is held every other year. This year it was held on October 27-30, at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida.<div>
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This conference is a huge event, attracting researchers and clinicians from all over the world. There are workshops, presentations, poster sessions and numerous networking events. It is an exciting gathering, and a wonderful opportunity to hear the latest in ME/CFS research.<br /><div>
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Traditionally, Dr. Komaroff gives a summary of the notable research presented at the conference. </div>
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Mary Schweitzer has generously provided the summary below with this note: <i>This is my best effort of transcribing Komaroff’s summary of the 2016 meeting - feel free to repost</i>.<div>
<br />-----------------------------------------------------------<br /><br /><b>Komaroff summary of 2016 IACFS/ME meeting</b><br /><br />In the past two years, since the 2014 SF meeting the report of the IOM based on a review of other 9.000 published articles concludes that ME/CFS is a “biologically-based illness”<br /><br />Announcement of expanded research activities by the National Institutes of Health and educational efforts by the Centers for Disease Control and Prevention.<br /><br />Evidence from this meeting of a biologically-based illness:<br /><br />Studies of:<br /> - Post-exertional malaise<br /> - Immunologic findings<br /> - Microbiome studies<br /> - Brain and nervous system studies<br /> - Epigenetic studies<br /> - Energy metabolism<br /> - Miscellaneous<br /> - Diagnosis and treatment<br /><br /><b>Studies of post-exertional malaise (PEM)</b><br /><br /><i>Detailed analysis of the components of “post-exertional malaise” (Stanford</i>)<br /> - Physical and cognitive exertion trigger PEM more often than emotional distress.<br /> - PEM includes not only fatigue, but also cognitive difficulties, sleep disturbances, headaches, muscle pain and flu-like symptoms<br /> - PEM lasts 3 or more days in approximately 25% of people.<br /><br /><i>Exercise testing in patients with ME?CFS vs. healthy controls</i>:<br /> - Triggers a characteristic gene expression “signature” involving 15 cytokines/adipokines/growth factors (Stanford)<br /> - When repeated 24 hours after a first exercise test leads to a significant decline in peak heart rate (“chronotropic incompetence”), which could contribute to post-exertional malaise (U of the Pacific)<br /> - Leads to postural tachycardia after exercise (as contrasted to after tilt table testing) in a subset of ME/CFS patients and Gulf War Illness patients, due to increased sympathetic activity (Georgetown)<br /><i><br /></i></div>
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Exercise testing in patients with ME/CFS vs. healthy control subjects:<br /> - Leads to lower oxygen consumption and earlier conversion to anaerobic metabolism (Nova and Wisconsin)<br /> - Blood lactate levels in 2nd exercise test after 24 hours<br /> - ME/CFS patients lactate levels are higher at all work loads<br /> - Healthy controls: lactate leels are lower at all work loads.<br /><b><br />Immunology</b>:<br /><br /><i>Huge study: 192 cases, 392 healthy controls</i>.<br /> - Levels of 17/51 cytokines/adipokines/growth factors were significantly different in ME/CFS than healthy controls<br /> - Most of the cytokines were pro-inflammatory, and their levels correlated significantly with the severity of symptoms (Stanford University)<br /><br />Interesting because many clinicians and researchers in this field have long believed that the disease was caused by abnormal cytokines in the brain.<br /><br /><i>The errant B cell</i>:<br /> - The early rituximab studies, indicating therapeutic benefit in some patients (Bergen, Norway)<br /> - Reduced diversity and increased clonality of B cells in ME/CFS<br />(NCNP, Japan)<br /><br /><br /><i>Microbiome</i>;<br /><br /><i>How the Microbiome may affect the brain</i><br /> - The human microbiome: 10 times as many bacterial cells as human cells, containing 5-8 million genes compared to our 20,000+ genes<br /></div>
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<i>Microbes in our gut</i>:<br /> - Synthesize hormones and neurotransmitters (e.g. norepinephrine, serotonin, dopamine, Ach, GABA)<br /><br /> - Synthesize molecules of inflammation (cytokines, prostaglandins) and elicit the production of those molecules by the gut immune system<br /> - Through inflammation, create a “leaky gut”: the tight junctions that bind gut epithelia cells together become loosened – allowing bacteria and bacterial toxins to enter the blood.<br /><br />In addition to the recently-reported reduction in bacterial diversity in ME/CFS, the team reports finding an increased number of Caudovirales bacteriophage viruses in ME/CFS.<br /><br />All of these findings point to low-level inflammation in the gut. (Cornell)<br /><br />--------------<br /><br /><b>Brain and Nervous System</b><br /><br /> - Impaired speed in processing information is shown to be a critical deficit in both ME/CFS and Gulf War Illness<br /> - Compared to healthy children, pediatric patients with ME/CFS had impaired information processing speed and attention. After exertion, these deficits worsened and ME/CFS kids also had poorer performance on tasks of working memory.<br /> - Impairments in cerebral blood flow and cortical glutathione levels – not affected by comorbid psychiatric disease.<br /> - A third of ME/CFS, but no healthy controls, had high white cell count or elevated protein in spinal fluid.<br /> - Altered heart rate variability, due to reduced cardiac vagal activity, in ME/CFS v. healthy controls. [There is some evidence that this can be a sign or contributory factor to heart disease later.]<br /><i><br />Functional connectivity among different brain regions impaired</i>:<br /> - Followed a cognitive test in ME/CFS v. healthy controls, determined by PET<br /> - As determined by diffusion MRI in GWI patients<br /> - As determined by EEG (eLORETTA) in ME/CFS patients at rest<br /><br />----------------<br /><br /><b>Epigenetic studies</b></div>
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<br /> - Disease is caused not just by mutated genes<br /> - It also is caused by perfectly normal, non-mutated genes, when those genes are not “expressed” (turned on or off) appropriately<br /> - Gene expression is controlled by many different “epigenetic” forces<br /> - Epigenetic studies are increasingly being done in ME/CFS v. healthy control<br /> - ME/CFS: genes involved in signal transduction are hypomethylated more often, whereas genes involved in cell differentiation/cell death are hypermethylated more often<br /> - ME/CFS: significantly different gene expression patterns for genes, involved in immune regulation (JAK-STAT pathway), hormone regulation and mitochondrial dysfunction.<br /> - Gulf War Illness: 19 related groups of genes (“functional modules”) were found to have significantly altered gene expression. Specific immunosuppressant and hormonal therapies were identified that might target these dysregulated genes, and possibly improve symptoms.<br /> - ME/CFS patients, compared to healthy controls, have 13 different gene loci, all involving glucocorticoid sensitivity that are differentially methylated. The different methylation patterns correlated with clinical symptoms<br /> - Characteristic expression of two particular microRNAs in plasma leads to elevated homocysteine levels identified in ME/CFS<br /> - Three SNPs distinguished ME/CFS patients from healthy controls. All involve a gene that codes for a subunit of NADH dehydrogenase – an important energy molecule.<br /> - MicroRNAs in spinal fluid predict orthostatic tachycardia after exercise.<br /> - No clear gene expression differences in ME/CFS v. healthy controls, at rest.<br /><br />----------------<br /><br /><b>Energy Metabolism Studies</b></div>
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<br /> - Studies on patients in the rituximab trial have an energy metabolism deficit, and the key molecule is the enzyme pyruvate dehydrogenase (PDH). Speculate that autoantiboedies may be the cause of this deficit. Upregulation of PDH inhibitors in white blood cells (Norway group – study will finish late 2017)<br /> - Peripheral white blood cells from ME/CFS produce energy less well than WBCs from healthy subjects, particularly when the cells are exposed to stressors.<br /> - Citric acid cycle metabolites are depleted. Glucose as an energy source is being replaced by fatty acids and amino acids<br /> - “Unbiased” metabolomics study finds that the metabolites that are most different between ME/CFS and healthy controls involve pathways harvesting energy from glucose, fatty acids and amino acids.<br /> - Also finds a general hypometabolic state, as did the recent paper from Naviaux (PNAS), though different metabolites were examined.<br /><br />---------------------<br /><br /><b>Miscellaneous</b></div>
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<b><br /></b> - ME/CFS patients, but not healthy controls, experience a worsening of symptoms following true (but not sham) strain: neuromuscular strain (even sitting/driving for prolonged time) may contribute to symptoms of ME/CFS. Physical therapy likely to help<br /> - Five specific findings on physical examination were quite accurate in diagnosing ME/CFS. This is of interest, since ME/CFS is defined exclusively by symptoms.<br /> - Of over 200 single-nucleotide polymorphisms examined, three – all located in the gene for NADH dehydrogenases – were significantly different in ME/CFS patients than in healthy controls.<br /> - ME/CFS patients have significantly higher anti-citrullinated protein antibodies than matched healthy controls, as is seen in the autoimmune whatever.<br /> - Particular mutations in two nucleosome transport genes distinguish ME/CFS patients from healthy controls.<br /> - A second case of ME/CFS caused by an enteroviral infection of the brain.<br /> - Impressive hypothesis: dysregulation in the production/release of Hydrogen Sulfide could explain many of the symptoms and objective abnormalities seen in ME/CFS<br /> - A subset of ME/CFS patients with sinusitis and/or hives has more pain and other symptoms<br /><br /><b>Possible Diagnostic Tests for ME/CFS?</b><br /><br />Four biomarkers – IL-8, sCD14, PGE2 and CD3/CD57+ count – correctly predicted ME/CFS in 97% of female cases (UNR)<br /><br /><i>An ideal diagnostic test would</i>:<br /> · Have very low false positive and false negative rates, compared to healthy controls and other fatiguing disease, when retested on a large number of new people<br /> · Be easy for perform reliably by many labs<br /> · Be inexpensive<br /><br /><b>Treatment Studies</b><br /><br /> · MRI spectroscopy revealed 15% lower levels of the natural antioxidant, glutathione, in the brain in ME/CFS patients compared to controls. N-acetyl-cysteine (NAC) treatment improved both brain<br />glutathione levels and symptoms, and reduced oxidative stress, in the ME/CFS patients<br /> · Randomized trial of low-dose methylphenidate plus a nutritional regimen designed to improve mitochondrial function. At 12 weeks, a trend toward reduced symptom that was not statistically significant; more severely ill patients seemed to benefit<br /> · A careful study of 990 ME/CFS patients found that patient beliefs about the cause of their illness did not explain their level of activity, a result that does not support the theoretical benefit of cognitive behavioral therapy.<br /> · Multimodel physical therapy improves symptoms in adolescents and young adults with ME/CFS and impaired range of motion.<br /> · Quantitative modeling identifies drug that are already FDA-approved and that might target TNA-alpha, IL-2 and the glucocorticoid receptor – targets that may be important in causing the symptoms of GWI<br /><br /><i>Multisite consortia to standardize and pool clinical and biosample data</i><br /> · CDC: Multi-Site Clinic Assessment (MCAM), with 7 collaborating centers. Biospeci and other things.<br /><i><br />Questions addressed by many presentations</i>:<br /> · In an illness defined exclusively by subjective symptoms, is there evidence of underlying biological abnormalities?<br /> · Could those biological abnormalities theoretically explain the symptoms?<br /> · Do the abnormalities in fact correlate with the symptoms?<br /><br /><b>In Summary</b>:<br /><br />Case-control studies comparing patients with CFS to both disease comparison groups and healthy control subjects find robust evidence of:<br /> · the brain and autonomic nervous system<br /> · immune system<br /> · energy metabolism<br /> · oxidative and nitrosative stress<br /><br />The illness is not simply the expression of physical symptoms by people with a primary psychological disorder.<br /><br />[Komaroff believes that new methods are getting us closer, quicker. Also the exercise evidence is changing the way people do research.]</div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-73323220814612224582016-10-11T03:29:00.000-07:002016-10-11T04:22:28.585-07:00Millions Missing Day of Protest Draws Attention to Plight of ME/CFS Patients All Over the Globe<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEimo4GjZ0yO-t2OuiBQyU1DnrKI1OzDJX8WsdJwFsS66qhlMVchkD1ZfJGHJR3MjBZNJBrN03aM3r_y45sqKjc8r9L_EHkT71_T8w1StKwGWXX1YY8Oc35QirEQLAJiJ8Zla9Tjo984Tqs/s1600/Millions+noho+shoes.JPG" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEimo4GjZ0yO-t2OuiBQyU1DnrKI1OzDJX8WsdJwFsS66qhlMVchkD1ZfJGHJR3MjBZNJBrN03aM3r_y45sqKjc8r9L_EHkT71_T8w1StKwGWXX1YY8Oc35QirEQLAJiJ8Zla9Tjo984Tqs/s400/Millions+noho+shoes.JPG" width="400" /></a></div>
<i>This article was first published on <a href="http://www.prohealth.com/library/showarticle.cfm?libid=29490">ProHealth</a></i>.<br />
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By Erica Verrillo<br />
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On September 27, <a href="http://www.meaction.net/">ME Action</a> sponsored the second Millions Missing global event. (The first was in May 2016.)<br />
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The purpose of the Millions Missing events was to draw public attention to ME/CFS, to demand increased funding into research for biomarkers and for effective treatment, and to improve medical education and patient care. (You can read the demands <a href="http://www.meaction.net/2016/09/22/us-millionsmissing-protest-demands/">HERE</a>.)<br />
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The global day of protest was a resounding success, with demonstrations in twenty-five cities in ten countries, and more being planned. The Millions Missing events drew ample media attention, as well as interest from government representatives and hundreds of passersby who saw the moving displays of empty shoes and stopped to talk to the volunteers – both patients and supporters – who dedicated their day to this worldwide effort.<br />
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I have selected some representative photos below, but to get the full impact of the event, I encourage you to browse ME Action's gallery of inspiring photos <a href="http://meaction.smugmug.com/MillionsMissing-SeptOct-2016">HERE</a>.<br />
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Please donate to this admirable initiative! This is the first time that there has been a coordinated international movement to bring attention to this disease, and to raise awareness at such an impressive scale. Millions Missing deserves our whole-hearted support! <br />
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<b>DONATE</b> <a href="https://www.crowdrise.com/millionsmissing-round-2">HERE</a>.<br />
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<b>UNITED STATES</b></div>
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<img height="427" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEj5CTj9bLLUePWfK6ZbeI4Rt1Ax9sR2d4p2hCveP_yc_wg_QS6lhKD_FLf53gRDsUVfm0Pbh8TwiDTfUPWRxXmICcRYO-ptxyx3vYSWqIwF9spuZjJli36FFUByzw0QqBbkAlY-eWS0B4kfYLqtB3RXIDbaEalQUX6CKu_SglBHCoHCfZHJR6n7vlO4VDszmIWjLmFR1g=" width="640" /><br />
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<b>ATLANTA</b></div>
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In Atlanta, Georgia, a group gathered at the State Capitol to give speeches about personal tragedies, the history of ME/CFS and hopes for a new science leading to a brighter future. State Representative Michael Caldwell was present and several other Representatives and staffers stopped by to listen and learn.<br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEipnZyckufOZhqcUh5RCAmP3pCymRrB67niO9ct8ZcjC-L_wJEZzol8rJM1ARvN1HLuff2WEVGxE01feKWBIUHnIZuvSguG5WmcWbDHzo42PLbZRsQlEOIpS3xAu2FdycghbFR0Spq3hHOTJ-2PLGGStplQsf8VHBSgzwn0KQoMiw8a=" width="640" /><br />
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<b>BOSTON</b></div>
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Patients and supporters met in front of the JFK building to raise awareness for ME/CFS. They laid out shoes, handed out flyers, displayed posters, and chatted with passersby. A couple of patients did performance pieces!<br />
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<img height="425" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEj0rdxvONx-irvxXyOlp_CFiX4UyY1iDC4PomxMZp5gSX20-xrC4GMdSuX_zwNtwBhAfLBtKu1PHXnCkFz7Opz3Z_4X1Fb-rH-QAqWb6LtI0bpIhylhWSo0303LWrXuW3q4bmOEro0fzxdRGiDRtBbhOzQ2Var8kONJk0PNJ43B1_bH3w=" width="640" /><br />
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<b>CHICAGO</b></div>
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Over 70 patients gathered outside the James Thompson Center in Chicago. Carol Head spoke as a patient and the president of SolveME/CFS Initiate stating "we will no longer be ignored." She focused her speech on the Institute of Medicine's report. Leonard Jason spoke about the severity of the disease and Marcie Zinn described the brain research she is working on at DePaul University in Chicago.<br />
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Press: <a href="http://www.beachwoodreporter.com/politics/hicago_residents_protest_lack.php">Chicago Residents To Protest Lack Of Support For Those Suffering With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome</a><br />
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<img height="425" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhsv0-HTQgowAiFDnHrloXa9evRxLESRsijdh4Sq53tcFylQCvgO2BPQ-7jcKjZM05AR3cKVewEr_V0arQUxiROfdLU9ssdVLnLtVXVvuMW9s8PabYXM0ttb9ul0zGmKeKGvw2iZG6Ij9PWVzNFnVY7CYpUQAPBbHl6I2mcegieuQdK=" width="640" /><br />
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<b>DALLAS</b></div>
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Eight people attended the Millions Missing protest at Dallas City Hall Plaza. A 25-foot banner was displayed among posters and photos of patients who were unable to attend. The protest demands were read and posted on Facebook live.<br />
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<img height="360" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEjNqxPw6_YkaQuLs2SdqYpfwEI47Q0RkR9VajiVJ_S8yynh5EzpxIzkNF87ZU1XlhDeThq9rgC7f591vsLUdEIv7t3Ex6iJEtwYEeQq7mx5XhtxxZZriuVp_td27tGyphMT-RZ8v2gBG_doq5cX1t2tZXT4NZ3aO-P1QCVJh97NznqmVQ=" width="640" /><br />
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<b>LANSING</b></div>
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The Lansing #MillionsMissing protest was held on the East steps of the Michigan State Capitol building, and several local news crews were present. Nineteen attendees from all over Michigan held signs and sat on the steps under a large banner. Patients shared their stories, and there was a long moment of silence for those who have died and those who are bed-bound.<br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEigxG7Kk-mLhx5g_zyBri4cwOep41iI-himPw0giPmqtjLHEFa8pVs2mUdWRhXN8xswHQiN8wu2Uf11AJ8N8355z0ql6ACMwvAKpxu-3vFBjD5rewAimRSH_crUqPoE2Gzc8iVSpxqwlHJUiZIkSKc2CUsx7iN9USqy3ZPFpClDZAM8v1ii8Q=" width="640" /><br />
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<b>MORRISTOWN</b></div>
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In Morristown, NJ, the demonstration lasted from 3:30 - 8:30 PM. Many people stopped by to learn more about ME/CFS, as well as the lack of funding and support from the NIH, CDC and HHS. The patients who were able to stop by were very grateful for this initiative.<br />
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<img height="511" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhAFhKDCmsTGMzTRnUOQf_tyhTuBDbEVl3HeP1Z4Cp_Lj2WawbToyHxq2V-9KjNazFU1NPXnNxQ6D9sTtp1CTVquUIfxPJgVafT-ts5BMGV4h2e0U9V7h8GbMSYJQY9XEJAa2mmCBnbhBhYEUqdoGdBQfe-TfFj0ie-9MuEvZQRIlp6UEZz-t_8qBEsqLh0e2hjUbMuirZCYA=" width="640" /><br />
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<b>NEW YORK</b></div>
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The NYC protest had approximately forty people in attendance with a full agenda of speakers. Dr. Susan Levine, Dr. Mady Hornig, Jim Eigo (ACT UP/NY), Annette Gaudino (Treatment Action Group), ME Activist Terri L. Wilder as well as other people living with and affected by ME spoke at the demonstration. A few reporters showed up and at the end of the demonstration Terri and Annette attempted to deliver a "bad report card" to the HHS regional office director but were stopped by building security and threatened with a citation! (See pictures in NYC photo folder <a href="https://meaction.smugmug.com/MillionsMissing-SeptOct-2016/United-States/New-York-NY/">HERE</a>.)<br />
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After tweeting "at" Jackie Cornell, HHS Regional 2 District Director, and asking her what she has done for New Yorkers with ME, ME Activist Terri Wilder received a private tweet from Ms Cornell stating "I'd love to sit down and discuss. I'm in DC a few days of this week and next but please email me and we can set up a time. Thank you for your advocacy and reaching out!"<br />
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Press: “<a href="http://www.businessinsider.com/me-cfs-protest-government-2016-9">More than a million Americans are suffering from a debilitating disease that makes simple tasks impossible — and they’re fed up with being ignored</a>,” Business Insider<br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi9tGaaqtjkscMwPsFvzcdfiLiy_Bv2GQsb7QcBwZPkoN1qdRolJDCVn8aRi5GiHesG4iYLu0JVqQJeRnY5ciOwqNwpTOnPNJiVgVzBICdmiBOKmlVHHOhfuDpN2Y3bzJb7xpumzCUCueoRLySBnxjWNtWgAVhI5PpJpbx235RLElxyBHRYedE=" width="640" /><br />
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<b>NORTHAMPTON</b></div>
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About a dozen patients and supporters gathered in front of City Hall in Northampton, MA. Passersby stopped to look at the display of shoes on the steps of City Hall, as well as read handouts and talk about ME/CFS with demonstrators. Lisa Hall, RN, from Northampton Wellness Associates gave a speech about the countless patients with ME/CFS she has seen, and described the severity of the disease. One patient spontaneously went into the town hall to invite the mayor to come down and visit. He did, and after speaking with the demonstrators offered a City Proclamation making May 12 official recognition day for ME/CFS.<br />
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Press: The local NBC station came and shot footage for a TV piece that ran on the evening news: <a href="http://wwlp.com/2016/09/27/millions-of-americans-suffer-from-chronic-fatigue-syndrome">http://wwlp.com/2016/09/27/millions-of-americans-suffer-from-chronic-fatigue-syndrome</a>.<br />
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<img height="427" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEiHpcb1uIkvpKN1X7mEai1Vr3y70R_GexdKHgBdq2oc01IpEdU-Od1j8_aH6VrPss1aocvAc4GH_ZezVP91mipzW-Jfs7D4PuNKza6YqjAxKT91iqOb6rj90w4vG-8JipG5GYQ2A_azn5uRIIY54PFzFW7wSB2WhYHP9oUdZUf_n161Mo-dKVZk5zI=" width="640" /><br />
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<b>SAN FRANCISCO</b></div>
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Well over 100 people showed up for the Millions Missing day of action in San Francisco. Over 150 patient profiles were stretched across 120 feet and a 60-foot quilt made over 17 years ago was displayed. The quilt was a created in three countries as a desperate plea for visibility and funding.<br />
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Hundreds of individuals passed these displays, many of them stopping to look for several minutes and ask demonstrators about the illness. Patient Sonya Heller Irey gave a passionate speech about the devastation this disease can inflict on an individual. A proclamation provided by Mayor Ed Lee was announced, naming a day of Awareness for ME in San Francisco, and a certificate of honor was issued by the San Francisco board of supervisors in recognition of the advocacy of the Millions Missing campaign.<br />
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Groundbreaking ME/CFS researchers, Dr. Eric Gordon, Dr. Ron Davis, and Dr. Jose Montoya, attended this event. Dr. Eric Gordon talked about potentially having a biomarker in the near future based on the recent metabolomics study.<br />
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“CFS/ME has devastated the lives of millions of people worldwide. The pain, suffering and solitude that this disease has brought to so many human beings is immeasurable. For the past 35 years, CFS / ME patients have been ignored, humiliated, misdiagnosed, mistreated and told that the disease is the product of their imagination. As a clinician investigator at Stanford University, when I close my eyes and I see the disease in all its enormity and complexity, I can only conclude that this is likely one of the greatest medical and scientific detective stories we face in the 21st century,” said Jose Montoya, professor at the Stanford University Medical Center.<br />
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Dr. Ron Davis added. “Unfortunately this [protest] is really necessary…. NIH funding gives you a steady state level of funding for five years so you can plan and you can hire people and you can do a much more effective job of doing the research... it’s not about doing one study, it’s about a sustained effort to figure it out and that’s why we need government funding in this project.”<br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEgbzsSuNOJIjHs8Sq2krCS_Bt6k25kVwSyQ6omAxZpKcz9Fi-j6z4DrluBisFVfw5FTkNSGBt0UAMhi2BosoEX8_ooDdViZOWo1y8tFIzBU6NJ384DotjpUgxQ-LWic3z71umZyn7Vwz03jZLiRoeL0bv4aK1yH2ZCABPAYvM5JTYyZXQ=" width="640" /><br />
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<b>SEATTLE</b></div>
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Demonstrators handed out flyers and held up signs for about two hours while passersby stopped to talk. Those who stopped were saddened and surprised by the fact that many people get so ill they can no longer work at all and stay in bed most of the day. It was a wonderful opportunity to come together to spread awareness of this debilitating disease.<br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEjeAHJLbWTVIAaVJxlkh34jInoL65WJl1diGTxLLzhZNqCTrySGpL62rLETV22_-WLRkuLDSELHG1rNn_QpapV4eW7ZpFUBGUPovE9IyCVg7Rsv3p0TjTNAWp4xk821nWSdTdS4LW4_lrhHL3Do-xOq1VDvHzBSjuNL8k3QMxW3vpCqeLxnAQ=" width="640" /><br />
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<b>WASHINGTON, D.C.</b></div>
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A large protest was held at the U.S. Department of Health and Human Services in Washington. Speakers included Ryan Prior and Hillary Johnson. Laura Benson and her husband, a retired Air Force officer, also gave compelling speeches. Three journalists covered the event, and the Montgomery County Council (home of NIH) issued a proclamation supporting ME/CFS awareness day. <br />
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Press: #<a href="https://www.inspire.com/Chronic-Inspire/journal/in-photos-millionsmissing-me-cfs-protest-in-washington-dc/">Millionsmissing ME/CFS Protest in Washington, D.C.</a>,” Inspire<br />
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<b>CANADA</b></div>
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhYYY85xotHJwXfufyLH6g7EA15T3VzAagVJFl0k9PrOgzVi31WgC3j0gQyG8toEeRCn5N7joyRN9uwb2FQ8OOXG5Tq9VrlXlI3VZsict-8ERhq_pm9egFAOcbw17WaUXs9b4Eo-3tbcX7rjqbQ_lSXLQKzO9MwSlinF4CJh4eArk0e=" width="640" /><br />
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<b>TORONTO, CANADA</b></div>
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A protest was held at the Health Canada Regional Office at 180 Queen St West, Toronto on October 6, from 12 - 2PM. ME/CFS specialist Dr. Alison Bested attended the event. <br />
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You can find more information here: <a href="https://www.facebook.com/events/1120173071406359/?active_tab=posts">https://www.facebook.com/events/1120173071406359/?active_tab=posts</a><br />
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<b>UNITED KINGDOM</b></div>
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<img height="427" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi3ezWHFlJERqzPVzaZ2iRT9uHzbtavCjJLK5EJNA2PqXrjSJ0ul8R_Z2XLTnQ7Qp-Flu7oxO5KZd9EUJ8nSLdu-tTKJ6LgtO2KgoffN5pPNw537GajOB9_uQEkE1pIQxpDFl0-uorOOzBKcTQm27lggdlSKv-QJwNfI2Pfa4s9xZN4=" width="640" /><br />
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<b>LONDON</b></div>
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“The day was in equal measures surreal, empowering, saddening and desperately emotional. The sense of brotherhood felt almost palpable as we stood together and spoke about our experiences with ME – our personal struggles, our deepening concern over graded exercise trials, particularly in children, and how one mother now cares for her husband and two children, all of whom suffer from ME.<br />
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We were grateful to have been live a total at least three, perhaps even four times throughout the protest thanks to London Live News (footage to follow) as well as grasp the attention of hundreds of passers-by with our strong words, our prominent display of shoes, and of course, our naked protester holding up the sign, You can’t ignore ME now.”<br />
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PRESS: “Striking protest about ignored ME sufferers outside the Department of Health in London today #MillionsMissing” (Christopher Hope, Assistant Editor and Chief Political Correspondent, The Daily Telegraph, on Twitter)<a href="https://twitter.com/christopherhope/status/780725734432247808">https://twitter.com/christopherhope/status/780725734432247808</a><br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEipeQpzbK8NTe41odQNh6DUOZepfQp5C2JCXdK0SlSNUVWy9lQFRoRWnA-XmrTL24T4YVqkD-mtXxXqmU7bMOP1UAQWVxFzNqaFiBJVe-3x6v5_fe2Snqkt_GMQv9ZAbMaELESYCR4L1b9I-pM8Sm5J7E0EDKuyjaPds3HztnAWWVwT3g=" width="640" /><br />
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<b>BELFAST</b></div>
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Dozens of shoes were laid out at Stormont, the seat of the Northern Ireland Assembly. Twenty-seven protestors held signs, including Sally Burch, long-time patient and Trustee of Hope 4 ME and Fibro. According to the Telegraph, Ulster Unionist health spokeswoman Jo-Anne Dobson MLA hosted the campaign. She said: "The sheer passion and drive of campaigners on display today at Stormont must be met by real and positive change in the treatment of thousands of patients across Northern Ireland."<br />
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Press: “<a href="http://www.irishnews.com/news/northernirelandnews/2016/09/28/news/demonstrators-at-stormont-urge-more-research-into-chronic-disease-m-e--712221/">Demonstrators at Stormont urge more research into chronic disease ME</a>,” The Irish News, 28 September 2016<br />
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“<a href="http://www.belfasttelegraph.co.uk/news/northern-ireland/me-sufferers-step-up-drive-for-more-help-35084826.html">ME sufferers step up drive for more help</a>,” Belfast Telegraph, 28 September 2017<br />
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<img height="428" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEiOAF2jQMptkOWh_wRWpR4kzwvlKhjtYJD3RZqDZHgAD3tW9aI8cUSe0aXoNtZ-RfGibfwGnl3e4u6sxhS4mwxUeBh8tj61wushBSu9kPWRUd9S3EApm0x2NJX_SrWT5FvVEw4xp_R8g_CN-Mzd-8DL2EVn3d95zw0nJg5dhR8e7hY1fA=" width="640" /><br />
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<b>BRISTOL</b></div>
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Bristol displayed 150 shoes on College Green in central Bristol, for a day of protest on behalf of the Millions Missing. ME patients, loved ones and family members gave out leaflets and talked to passersby, most of whom were visibly shocked to learn the truth about this devastating illness. One individual stayed for almost an hour reading every single label on every pair of shoes. Many wanted to donate to fund research.<br />
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Press: BBC Radio Bristol (at 2hrs 11mins):<a href="http://www.bbc.co.uk/programmes/p046wd9k">http://www.bbc.co.uk/programmes/p046wd9k</a><br />
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Bristol Post: <a href="http://www.bristolpost.co.uk/100-pairs-of-shoes-make-silent-protest-on-me-research-in-bristol-city-centre/story-29755005-detail/story.html">100 pairs of shoes used to make poignant protest on ME research in Bristol city centre</a> <br />
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<img height="480" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEjoLojj9Ram-EuWtF8qTNsIP0tiNb_ur5rFcmrNNoJFgb3dxNeXnkycm9BN58mHQvRtdMj7pt1YXxQ_z1JT13HrnHmr9UxUyRCoyIcp2WBfnnfyhvUItUT1Ff8ip8pNJ4O0wVeIzb3VngeL8CfeyE7xUF1mfF_M_LwEB8eCdKsrlQ_0rg=" width="640" /><br />
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<b>CARDIFF</b></div>
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The Millions Missing event in Cardiff was held on the steps of the Welsh Assembly that looks out over Cardiff Bay. Rows of empty shoes were a very poignant reminder of what the demonstration was all about. The Cardiff Rock Choir volunteered their services free of charge and drew the attention of passersby. A dance trio also performed, adding to the day.<br />
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A number of Assembly Members came out to speak with the demonstrators, including Julie Morgan who sponsored the group. Jan Hutt Assembly Member for the Vale of Glamorgan also came out onto the steps of the Assembly to speak to the demonstrators. Other Assembly Members stopped to find out more about Millions Missing, including Vikki Howells AM for Cynon Valley, David Melding AM for South Wales Central, and Dai Lloyd AM for South Wales West.<br />
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Press: Made in Cardiff TV came to film the event and presented a good report at 6 pm and 9 pm on their Tuesday evening News.<br />
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<img height="640" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEjEl6zqQUY1JR7TbVwo7aG0H46-UjN-WjgxZIlG5Q23qEl-xH7yz1z_YDcRgO7BxAjhHDJK_igA69ZMVlzY7_BY9E-UnhIqF1gsxBFU6dCCfikxYFGP_vHpnwb20Hv37YM6l32BojGHS8GyIyatKMZkSzc49bMIdm0FVihuOt-3oEOCQIROLA=" width="480" /></div>
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<b>NOTTINGHAM</b></div>
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About 15 patients, family and friends gave out 200 flyers, spoke to 300 people, and got 30 signatures to stop GET trials on children. A passing ME patient couldn't believe that someone was standing up for ME "as people never do anything for us."<br />
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Press: BBC Nottingham Radio, covered on news bulletins throughout the day and had a 10-minute segment (about 5:20) as part of drive show (prime driving home from work time)<br />
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BBC East Midlands Today covered the demonstration on local TV news on the evening news segment. They filmed at the event and at a patient’s home.<br />
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<img height="640" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEh9McYnKsSLypfA6Q8UCrG_P2UcMUbOjf96_uxq7mJW1y8G8BRDz8OeqA3N4joKreVzszzx5hUDpVDF6af-G4_3a_RNfNBMLgXMKwYEmigYPc03UhRzv7CVFZTSgWVOb0zEWedO2drlZpGyhiSkPiSJDqpHNFdQNbBItpmEoBlMl9wHeSoFgv4xioCvAui-pkyyJTYr=" width="480" /></div>
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<b>OXFORD</b></div>
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The Oxford event took place in front of the Radcliffe Camera Landmark. Over 100 pairs of shoes were laid out. Volunteers helped to hand out around 200 leaflets and explained ME to curious passersby, many of whom stopped to read the shoe tags describing each sufferer's experience with ME.<br />
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Press: <a href="http://www.bbc.co.uk/programmes/p047q772">BBC Radio Oxford</a><br />
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<a href="http://www.bbc.co.uk/iplayer/episode/b07vw7cm/south-today-late-news-27092016">BBC South Today</a><br />
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<a href="http://www.oxfordtimes.co.uk/NEWS/14765529.Rows_of_empty_shoes_will_represent__hidden__sufferers_of_debilitating_condition/?ref=rss">Oxford Times</a><br />
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<a href="http://www.oxfordmail.co.uk/news/14765529.PICTURE_UPDATE__Rows_of_empty_shoes_represent_hidden_sufferers_at_city_centre_protest/">Oxford Mail</a><br />
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<b>CONTINENTAL EUROPE</b></div>
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<img height="427" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhLYENBV8kN2R5faamdhjX_aY1hL3JegniQUmVzYyF0KMDYl7vxTvXbh8Ys0OJjmlRmXUDDXOPG78rBCXguX6Y8py4Iw5p_cSMHQqmZnkyhyphenhyphenRvOaCycamQrJyyIGJm3gDNBZfX6T3v2ggDbFuLaXQvX0IiLpfqrDJPR-smN8t6LLg5HBcdiGE_6obQ=" width="640" /><br />
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<b>HAMBURG, GERMANY</b></div>
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Patients and relatives met at the Hamburg harbor to raise awareness of ME/CFS. People came from all parts of the country and there was huge virtual support.<br />
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“ME/CFS must be considered as a severe physical illness. It’s time to take us seriously!” said Daniel from the German Society of ME/CFS. Nicole from the Lost Voices Foundation pointed out that “Patients are left alone! This day is so important for us to raise awareness of ME and to eventually improve overall care and treatment.”<br />
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<img height="427" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEgigrgLIPyzIg-0OesTu3Jddy1OyE-UiPBH9AJasdK1W2Gt-4e4t9rx9fxwXtqsBy4Db8b71ZTUboelFizZcQ7YQzPLM7DWxp6H8o_zs1jtizJn20QMrAoaRzts3JKWETlTSMx7DJGUN6_dTojKXZc0mbNvKJC0el_iAvPGuweYUBMoNSSU=" width="640" /><br />
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<b>THE HAGUE, NETHERLANDS</b></div>
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A Millions Missing protest was held from 10:00 AM to 4:00 PM in front of Parliament in The Hague. About 1000 pairs of shoes were displayed, which drew the attention of many visitors. Fifteen demonstrators handed people flyers and talked with them about ME. Dr. Frans Visser gave a speech. The group spoke to two members of Parliament from two different political parties.<br />
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Press: <a href="http://denhaagfm.nl/2016/09/26/me-patienten-plaatsen-duizenden-schoenen-op-het-plein/">ME Patients Display Thousands of Shoes on the Square</a><br />
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Omroep West: <a href="http://www.omroepwest.nl/nieuws/3247822/ME-patienten-demonstreren-op-Haagse-Plein-voor-erkenning">ME patients demonstrate in The Hague Square</a><br />
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De Telegraaf: <a href="http://www.telegraaf.nl/binnenland/26692997/__Stille_schoenenparade_voor_Tweede_Kamer__.html">Silent shoes parade before Lower House</a><br />
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Radio 1 interview with Carolien van Leijen: <a href="http://www.nporadio1.nl/achtergrond/1498-me-patienten-willen-meer-begrip-geen-opmerkingen-als-neem-een-hond">ME patients want more understanding, not comments like "get a dog"</a><br />
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Read more about Dutch press coverage <a href="http://www.me-gids.net/module-ME_CVS_docs-viewpub-tid-1-pid-1653.html?utm_source=twitterfeed&utm_medium=twitter&utm_campaign=me-gids-news">HERE</a>.<br />
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<img height="427" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEixOceLkZ121rJzdMAwaAvi07vvcv7U2M-9PLiKwZyikqJWK5jYeI8FH0x1oDpgf6rlXJse73yfY-gQttdE-41Qz_zGbbCFCI_waWXB0b85Y9G1xIyXuNFQi9wnXNkXMmRO0oNdwFI8nvm6fVbsglDDNlee-5YCUixDHkd6Gcf1pg=" width="640" /><br />
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<b>OSLO, NORWAY</b></div>
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Demonstrators in Oslo displayed 250 pairs of shoes and spoke with 300 passersby. Olaug V. Bollestad, a member of Parliament, and two speakers from patient organizations gave speeches. Three musicians performed. One patient group brought fruit and yoghurt for the participants to tide them through the event. The participants intend to start a collaboration with the Norwegian research fundraising group to help fundraise for clinical studies here in Norway.<br />
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Press: The demonstrators were interviewed by a national radio station at 3pm and filmed all day by a documentary filmmaker who is creating a documentary about ME and the Rituximab study in Norway. The film will come out in 2018. The event was filmed live and had about 120 people watching the live feed.<br />
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“<a href="http://www.side2.no/aktuelt/--de-meldes-til-barnevernet-for-omsorgssvikt/3423266782.html">ME: – De meldes til barnevernet for omsorgssvikt</a>,” Side Two, Sept. 27 2016<br />
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Additional links:<a href="https://www.facebook.com/elisabeth.royseth/posts/10153863829561680">https://www.facebook.com/elisabeth.royseth/posts/10153863829561680</a><br />
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<b>VIRTUAL</b></div>
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<b><b>SOUTH AFRICA</b></b></div>
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The recently formed ME/CFS Foundation South Africa held a virtual event. They asked patients for their stories and photos of shoes/activities they could no longer participate in, made posters, and posted these throughout the day on Facebook, posted on Twitter, sent the virtual event to numerous online newspapers. They also texted and emailed radio presenters throughout the day.<br />
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Press: <a href="http://sandtonchronicle.co.za/165664/shoes-for-a-syndrome">Shoes for a Syndrome</a></div>
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<b>MELBOURNE, AUSTRALIA</b><br />
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<a href="https://www.facebook.com/hashtag/millionsmissingmelbourne">#MillionsMissingMelbourne</a> will be held on 12 October at Victorian Parliament</div>
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Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-37446510146860127182016-09-10T05:07:00.000-07:002016-09-10T05:07:31.436-07:0055 Members of Congress Sign Letter Supporting Biomedical Research for ME/CFS<div class="separator" style="clear: both; text-align: center;">
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After dogged work by advocates, fifty-five members of Congress have added their signatures to a letter initiated by representatives Zoe Lofgren (D - CA) and Anna Eshoo (D - CA).<br />
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The letter urges NIH to respond in a timely fashion to requests for grants. It also asks NIH to report its efforts to fund research as well as the status of specific plans for funding over the next two years.<br />
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Congressional support is crucial for obtaining funding for research because unlike agencies, which are beyond our influence, representatives have an obligation to support the interests of their constituents.<br />
____________________</div>
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<a href="http://solvecfs.org/advocates-obtain-congressional-support-for-strengthened-mecfs-research-at-nih-2/" target="_blank">SCMI Press Release</a>:</div>
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<b>Advocates Obtain Congressional Support for Strengthened ME/CFS Research at NIH</b></div>
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LOS ANGELES, September 9, 2016 – After years of neglect by the National Institutes of Health (NIH), patients suffering from myalgic encephalomyelitis (ME), commonly known as chronic fatigue syndrome (CFS), created a win today as members of Congress came together urging the NIH to do the right thing and strengthen ME/CFS research.<br />
<br />
<a href="http://solvecfs.org/wp-content/uploads/2016/09/9.9.2016_Lofgren-Eshoo-Letter-to-NIH_ME-CFS.pdf">In a formal U.S. House of Representatives letter published today</a> (“the letter”), 55 members of Congress called upon NIH Director Francis Collins to strengthen the NIH’s efforts in ME/CFS biomedical research through a reinvigorated trans-NIH ME/CFS working group as well as additional intramural and extramural research programs.<br />
<br />
As the letter explains, “ME/CFS is a complex, debilitating, and chronic disease afflicting 1 to 2.5 million Americans. It costs individuals, the U.S. health care system, and our economy an estimated $17-$24 billion annually. Yet, as the Institute of Medicine noted in its report, ‘Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness,’ there has been ‘remarkably little research funding’ to date to discover its cause or possible treatments.”<br />
<br />
Thanks to the hard work of #MEAction, the Solve ME/CFS Initiative (SMCI), and dozens of independent advocates, the letter attracted a broad coalition of bipartisan cosigners led by U.S. Representatives Zoe Lofgren and Anna Eshoo of California. In addition to encouraging advocates all across the country to reach out to their own representatives, SMCI President Carol Head also wrote a personal letter to all 435 representatives, urging them to sign onto the letter.<br />
<br />
Said SMCI President Carol Head, “The NIH has failed to live up to its commitment to ME/CFS patients and has not followed the recommendations put forth in the 2015 IOM report; now, thanks to the actions of a coalition of hardworking advocates and members of Congress, we expect this to change.”<br />
<br />
To read the letter and see the 55 members of Congress who signed on, <a href="http://solvecfs.org/wp-content/uploads/2016/09/9.9.2016_Lofgren-Eshoo-Letter-to-NIH_ME-CFS.pdf">view the letter here</a>.<br />
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About the Solve ME/CFS Initiative (SMCI)<br />
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The Solve ME/CFS Initiative (SMCI) was founded in 1987 and has established itself as the leading non-profit organization dedicated to ME/CFS. The organization’s mission is to make ME/CFS widely understood, diagnosable, and treatable by stimulating and conducting research aimed at the early detection, objective diagnosis, and effective treatment of ME/CFS. SMCI is the first and only ME/CFS organization to earn the highest possible distinction (a 4-star rating) from Charity Navigator, America’s largest independent charity evaluator.<br />
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September 9, 2016</div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-52449800333585284202016-09-07T07:03:00.001-07:002016-09-07T07:13:41.296-07:00Tribunal Orders Release of PACE Trial Data: Is This the End of an Error?<div class="separator" style="clear: both; text-align: center;">
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On August 16, the First Tier Tribunal (UK) ordered the release of the PACE Trial data to Alem Matthees, marking the end of a two-year battle. (You can read the order <a href="http://www.informationtribunal.gov.uk/DBFiles/Decision/i1854/Queen%20Mary%20University%20of%20London%20EA-2015-0269%20(12-8-16).PDF" target="_blank">HERE</a>.)<br />
<br />
Mr. Matthees is an Australian researcher, and ME/CFS patient, who has made <a href="http://cfstreatment.blogspot.com/2014/06/the-big-lie.html" target="_blank">repeated attempts</a> under the Freedom of Information Act to obtain anonymized data from the PACE trial. Queen Mary University of Londom (QMUL) has managed to quash every request - until now.<br />
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In this historic ruling, the tribunal determined that:<br />
<br />
1) The information Mr. Matthees requested is not personal, and therefore an exemption based on the possibility that people in the trial could be identified does not apply.<br />
<br />
2) Because data are anonymized, invasion of privacy does not apply.<br />
<br />
3) There is no indication that the release of anonymized data would discourage future research.<br />
<br />
4) There is a strong public interest in releasing the data.<br />
<br />
This last point is especially important, as it directly addresses the issue of transparency in research, a topic that has been much in the news lately.<br />
<br />
In a <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124" target="_blank">2005 article</a> published in PLoS ONE, Stanford professor John Ionnides claimed that most published research findings were false. There are a number of reasons why research is falsified, including outright plagiarism, conflict of interests (especially true in cases where research is being paid for by pharmaceutical companies), poor methodology, scientific malfeasance, false premises, and general incompetence.<br />
<br />
In the case of the PACE trial, conflict of interests led directly to scientific malfeasance. The conflict here stemmed from the unwillingness of NHS to pay for treatment for ME patients. In comparison to treatments such as Ampligen, IVIG, and other immunotherapies, cognitive behavior therapy (CBT) and graded exercise (GET) are relatively cheap to administer.<br />
<br />
The PACE trial is not the first trial to make the claim that CBT and GET are beneficial for ME/CFS patients. Trudie Chalder, one of the principals in the PACE study, has been publishing articles since 1989 touting the benefits of CBT and exercise for ME/CFS patients. Nor is she a stranger to faulty methodology as the statistics on some of these studies were questionable.<br />
<br />
The PACE trial was the crowning glory to over two decades of research for Chalder, as well as for several other psychiatrists involved in the study. While it is unlikely QMUL will spend any more money on challenging the tribunal's decision, it is equally unlikely that the PACE trial group will abandon its "research" into CBT and GET. In fact, a second PACE study involving adolescents is already under way.<br />
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_______________________<br />
<br />
<i>Press Release from ME Action</i>:<br />
<br />
Thursday, 18th August 2016, London, UK - A tribunal has ruled that data from a treatment trial into<br />
Chronic Fatigue Syndrome (CFS) must be released, rejecting an appeal from Queen Mary University<br />
of London (QMUL).<br />
<br />
PACE was a £5 million, publicly-funded clinical trial of exercise and cognitive behavioural therapy for CFS. It has been highly influential in determining treatment in the UK and abroad, but has been<br />
controversial. Academics and patients have both voiced concerns over “misleading” claims. Dr<br />
Richard Smith, former editor of the British Medical Journal, said in December 2015 of QMUL’s failure to release the data, “…the inevitable conclusion is that they have something to hide”.<br />
<br />
QMUL spent over £200,000 on legal fees in this case, to appeal the Information Commissioner’s<br />
decision that they should release anonymised data from the trial. The request for data was made<br />
under the Freedom of Information Act by Mr Alem Matthees, to allow analysis of the data according<br />
to the study’s original published protocol.<br />
<br />
QMUL made several arguments why the data should not be released, their main claims being that<br />
the data was personally identifiable information, and was not sufficiently anonymised. However, the<br />
tribunal rejected these arguments, noting that QMUL had already shared the data with a small<br />
selection of other scientists, stating, "In our view, they are tacitly acknowledging that anonymization<br />
is effective, or else they would be in breach of the consent agreement and the DPA principles."<br />
<br />
The tribunal was satisfied that the data “...has been anonymised to the extent that the risk of<br />
identification is remote.” The tribunal also noted the "strong public interest in releasing the data<br />
given the continued academic interest" and "the seeming reluctance for Queen Mary University to<br />
engage with other academics they thought were seeking to challenge their findings."<br />
<br />
In his correspondence with the court, Mr Matthees expressed “concerns that QMUL are restricting<br />
the registered researchers to whom they disclose the data upon request.” The tribunal said, “The<br />
evidence before us is not clear but if QMUL are cherry-picking who analyses their data from within<br />
the recognised scientific research sphere to only sympathetic researchers, there could be legitimate<br />
concerns that they wish to suppress criticism and proper scrutiny of their trial.”<br />
<br />
In its submissions QMUL made a number of accusations of harassment from patients, while QMUL’s<br />
expert witness characterized PACE trial critics as "young men, borderline sociopathic or<br />
psychopathic", remarks the Information Commissioner dismissed as "wild speculations".<br />
<br />
When pushed to provide evidence of these threats and harassment under cross examination,<br />
witnesses speaking for QMUL were unable to do so, and ultimately conceded that "no threats have<br />
been made either to researchers or participants."<br />
<br />
The tribunal found QMUL's assessment of activist behaviour to be, “grossly exaggerated” stating<br />
that “the only actual evidence was that an individual at a seminar had heckled Professor Chalder.”<br />
[Professor Chalder is a leading researcher in the PACE trial and a key witness for QMUL.]<br />
<br />
<b>Expert reaction to the decision</b><br />
<br />
Jonathan C.W. Edwards, MD<br />
Emeritus Professor of Medicine<br />
University College London<br />
<br />
“I think this is the right decision and I congratulate Mr Matthees on persevering with a very<br />
reasonable request. The report indicates that the Tribunal considered arguments from both sides<br />
very thoroughly. It has become clear that the reasons given for not providing the information<br />
requested are essentially groundless. It is also clearly appreciated that critics of the PACE trial are<br />
not young sociopaths - they include senior medical scientists like myself, concerned about poor<br />
science!”<br />
<br />
Bruce Levin, PhD<br />
Professor and Past Chair<br />
Department of Biostatistics<br />
Columbia University<br />
Mailman School of Public Health<br />
722 West 168th Street<br />
MSPH Box 12, Room 647<br />
New York, NY 10032<br />
<br />
“I am heartened by the Tribunal’s finding that the Commissioner had reached a correct decision in<br />
ordering release of anonymized data for the PACE trial. The Tribunal’s assessment that the<br />
perceived risks of data release were neither substantiated nor demonstrated in the evidence before<br />
them and that such minimum risk as had been expressed to them would not in their view outweigh<br />
the public interest in disclosure of the disputed information is quite important, not only for patients<br />
in this trial and around the world, but also because it underscores how essential transparency and<br />
open, critical review of clinical trials are to the scientific method.”<br />
<br />
Keith Geraghty, PhD<br />
Honorary Research Fellow<br />
University of Manchester<br />
<br />
"I read the tribunal decision with great interest. I was surprised that the PACE authors declared in<br />
evidence that they had shared their trial data with other researchers. I contacted lead author Prof.<br />
Peter White to request access to PACE data to run an independent analysis, but my request was first<br />
ignored, then later refused. I now understand that the authors shared the data with a select few<br />
academics who they picked to co-write papers, but they have failed to share the data with the<br />
broader scientific community. Selectively sharing this publicly-funded data with collaborators but<br />
refusing to share data with anyone else, is not in the best interests of patients or science, and it<br />
creates a perception that the PACE team do not want independent critical analysis of this trial. I find<br />
it regrettable that the Medical Research Council, who partly funded this very expensive study, did<br />
not specify that the trial data be made available to other researchers.”<br />
<br />
Dr Charles Shepherd<br />
Hon Medical Advisor, ME Association<br />
<br />
“The tribunal decision to firmly reject the QMUL case for not releasing anonymised PACE trial data<br />
will be widely welcomed by the ME/CFS patient community.<br />
<br />
This means that there can now be an independent analysis of data from the PACE trial that has been<br />
used to support a number of conclusions and recommendations regarding the benefits of CBT and<br />
GET in ME/CFS that are just not consistent with patient evidence for these interventions<br />
Having attended the hearing, where a number of unsubstantiated and serious accusations were<br />
made against the patient community, I am pleased to see that this 'red herring' was also rejected by<br />
the tribunal. I hope that QMUL will now accept this judgement to release the data and do so without further delay and that they will not spend any more public money on an appeal.”<br />
<br />
David Tuller, DrPH, Investigative journalist and public health expert<br />
University of California, Berkeley<br />
<br />
"This decision is a thorough repudiation of the efforts by the PACE investigators to protect their<br />
claims and findings from being exposed as utter nonsense. You don't actually need the data to<br />
determine that the trial is a piece of garbage, but having the data at last will make it clear to<br />
everyone. They will likely appeal, but they will ultimately lose."<br />
<br />
Alem Matthees<br />
Patient and Second Respondent<br />
Australia<br />
<br />
I am very pleased with this outcome. Both the Tribunal’s decision and commentary are a long<br />
overdue victory for the patient community, as well as for advocates of clinical trial transparency and<br />
open data sharing. I want to thank everyone who gave support, advice or assistance, as well as<br />
anyone who engaged in debate over the PACE trial and the sharing of clinical trial data. This case<br />
ended up costing me greatly in time, energy, and health (currently bedridden).<br />
<br />
I utilised the FOIA to loosen the vice grip control over the data and allow truly independent and open<br />
analyses that do not rely on the approval of QMUL or the PACE trial investigators. All this came<br />
about largely because of their refusal to publish or release the protocol-specified outcomes, and<br />
their generally questionable and poorly or erroneously justified changes to the published trial<br />
protocol, i.e. outcome switching, after the trial was over and/or after seeing trial data. Claims of<br />
clinically significant improvement may be open to interpretation, but false or misleading claims of<br />
recovery or remission from debilitating illness simply have no place in the scientific literature.<br />
<br />
Tom Kindlon<br />
Information Officer<br />
Irish ME/CFS Association<br />
<br />
I hope Queen Mary University of London won't appeal again and cause more public money and<br />
resources to be spent on the case. Now that a court has ruled that the data is non-identifiable and<br />
that releasing it will not contravene agreements with trial participants, there is no good reason to<br />
continue to withhold it. If QMUL appeal, people may suspect this case was at least partly about<br />
trying to hide inconvenient results. Indeed, the tribunal decision notice itself raised the question of<br />
whether QMUL may wish to avoid proper scrutiny of their trial.<br />
<br />
Patients want nothing more than to recover from this condition, so misleading claims about recovery<br />
rates are a particularly serious matter. Many are very sceptical of suggestions they can recover with<br />
talk therapy or by steadily increasing their levels of exercise. This is not their experience.<br />
<br />
Extraordinary claims require extraordinary evidence but the researchers have not yet released such<br />
evidence: they revised all four aspects of the recovery criteria to make it much, much easier to be<br />
classed as recovered and have so far failed to provide valid justifications for these changes. Some of<br />
the PACE Trial investigators have conflicts of interest, such as doing work for insurance companies,<br />
which can make people concerned about bias.<br />
<br />
This is a huge victory for patients, who have a right to examine the evidence for the treatments that<br />
affect their lives. I expect that the recovery rate will only be a small fraction of what the PACE<br />
researchers claimed, due to the dramatic changes they made to the criteria.<br />
<br />
Jane Colby<br />
Tymes Trust Executive Director<br />
<br />
"Tymes Trust is pleased at the judge's ruling. We believe that, pending independent analysis of PACE<br />
data, the MAGENTA (PACEstyle) study in children should be suspended immediately."<br />
<br />
Leonard A. Jason, PhD<br />
Professor of Psychology and Director<br />
Center for Community Research<br />
DePaul University<br />
990 W. Fullerton Ave.<br />
Suite 3100<br />
Chicago, Il. 60614<br />
<br />
“I believe that an independent analysis of the controversial trial would be in the best interest of<br />
scientists, clinicians and patients.”<br />
<br />Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-12630168306859498872016-09-05T05:53:00.001-07:002016-09-05T05:53:09.291-07:00Approval for Commercial Sale of Ampligen to Treat Severe Cases of ME/CFS in the Argentine Republic<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiR6GfS-ilOGutEy9oy-HsFftuA55iVIjQpkg4wh0u2n-0H1aa5-Pu5Q9h2FFGIHfyhu5KTJr4ZlmernXxG6dC_vR8icK81iyHuAjAOTJC1QWB2fMt7p1xz-qRYUTYIOL5ztpUJq_4cEdw/s1600/ampligen.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="225" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiR6GfS-ilOGutEy9oy-HsFftuA55iVIjQpkg4wh0u2n-0H1aa5-Pu5Q9h2FFGIHfyhu5KTJr4ZlmernXxG6dC_vR8icK81iyHuAjAOTJC1QWB2fMt7p1xz-qRYUTYIOL5ztpUJq_4cEdw/s400/ampligen.jpg" width="400" /></a></div>
At long last, Ampligen is approved somewhere. Not here, unfortunately, but it's a first step. With Argentinian approval, there is the possibility of approval elsewhere. <div>
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More to the point, in Argentina at least, there is official acknowledgement that ME/CFS is not a psychological illness.<div>
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__________________<br /><br /><br /><i>Breakthrough Approval Provides Clear Path for Growth in Latin America and the European Union</i><br /><br />PHILADELPHIA, Aug. 26, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced that it has received approval of its New Drug Application (NDA) from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The product will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. We believe that rintatolimod is the first drug to receive approval for this indication anywhere in the world. We also believe that there are no other products in the pipeline for approval, worldwide, for this debilitating disease. A copy of the official approval from ANMAT, translated in English, is available on the Company’s website at <a href="https://www.globenewswire.com/Tracker?data=2QvQYwLqDMPDdAdxkfnmwK3ECtEH0aGuTX0vkFF5kHgFfTKjeFbQVNy4PpgOlEHwmQamLcSwkZVjTskdH0A_Jm4lKmWOR3WN7cGSeoR3ov8xY6a_zgevQg3Rh3GI7EB25H1mHABy2uDussGS4LZ30A==">http://ir.hemispherx.net/Events_Presentations</a>.<br /><br />The approval was based on submission of two pivotal studies, AMP-502 and AMP-516. Safety data also included additional CFS and non-CFS studies for a total of over 800 subjects including over 100 subjects with severe CFS who received Ampligen® for one year or longer. Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina. “Working closely with our partner in this effort, GP Pharm, our team at Hemispherx addressed all medical and scientific issues presented by ANMAT and deserves great credit for this major success. At Hemispherx, we may be small by big pharma standards, but our commitment to addressing this dire unmet medical need makes us mighty,” stated Hemispherx CEO Tom Equels.<br /><br />Approval for commercial sale in Argentina provides a platform for potential commercial sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. Hemispherx and GP Pharm are now working to expand the approval of rintatolimod to additional countries with a focus on Latin America. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, adds further validation for the product as the Early Access Program (EAP) is launched in Europe.<br /><br />“In Argentina, rintatolimod (Ampligen) has just been commercially approved for the severe disabling form of ME/CFS. The number of patients with ME/CFS is estimated to be over three million worldwide, however, only a portion of these have the severe and disabling form of the disease which we are targeting with this drug,” stated Tom Equels. “Until now, there has been no commercially available effective treatment and there are no advanced clinical candidates, other than rintatolimod, that we are aware of. This commercial approval in Argentina will dramatically improve our ability to treat patients suffering from severe ME/CFS in Latin America. We continue to work aggressively to clarify a path toward approval for those with severe ME/CFS in the United States, where we have Orphan Drug status, and therefore seven years of product exclusivity upon approval. We are greatly encouraged by this new regulatory approval in Argentina. This is the most significant accomplishment to date in Hemispherx’s plan to bring our drug to severe sufferers of ME/CFS worldwide.”<br /><br />“We have worked diligently with Hemispherx to get to this point, and are now preparing for the commercial launch of rintatolimod for ME/CFS in Argentina,” commented Jorge Braver, chief executive officer of GP Pharm Latin America. “Looking ahead, we will continue to seek approval in additional Latin American countries.”</div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-67362941137702120402016-08-31T03:47:00.000-07:002016-08-31T03:47:12.156-07:00Researchers Identify Characteristic Chemical Signature for Chronic Fatigue Syndrome<div class="separator" style="clear: both; text-align: center;">
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By Scott Lafee<br />
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Press Release: <a href="https://health.ucsd.edu/news/releases/Pages/2016-08-29-chemical-signature-for-chronic-fatigue-syndrome-identified.aspx">U.C. San Diego</a>, August 29, 2016. Chronic fatigue syndrome (CFS) is a mysterious and maddening condition, with no cure or known cause. But researchers at the University of California San Diego School of Medicine, using a variety of techniques to identify and assess targeted metabolites in blood plasma, have identified a characteristic chemical signature for the debilitating ailment and an unexpected underlying biology: It is similar to the state of dauer, and other hypometabolic syndromes like caloric restriction, diapause and hibernation. <br />
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Dauer is the German word for persistence or long-lived. It is a type of stasis in the development in some invertebrates that is prompted by harsh environmental conditions. The findings are published online in the August 29 issue of <a href="http://www.pnas.org/content/early/2016/08/24/1607571113.abstract?sid=b50871d2-b872-4ab6-8cc7-b060c16c8748">PNAS</a>.<br />
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“CFS is a very challenging disease,” said first author Robert K. Naviaux, MD, PhD, professor of medicine, pediatrics and pathology and director of the Mitochondrial and Metabolic Disease Center at UC San Diego School of Medicine. “It affects multiple systems of the body. Symptoms vary and are common to many other diseases. There is no diagnostic laboratory test. Patients may spend tens of thousands of dollars and years trying to get a correct diagnosis.”<br />
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As many as 2.5 million Americans are believed to have CFS. It most often afflicts women in their 30s to 50s, though both genders and all ages can be affected. The primary symptom is severe fatigue lasting at least six months, with corollary symptoms ranging from muscle pain and headaches to sleep and memory problems.<br />
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Naviaux and colleagues studied 84 subjects: 45 men and women who met the diagnostic criteria for CFS and 39 matched controls. The researchers targeted 612 metabolites (substances produced by the processes of metabolism) from 63 biochemical pathways in blood plasma. They found that individuals with CFS showed abnormalities in 20 metabolic pathways. Eighty percent of the diagnostic metabolites measured were decreased, consistent with hypometabolic syndrome or reduced metabolism. The diagnostic accuracy rate exceeded 90 percent.<br />
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“Despite the heterogeneity of CFS, the diversity of factors that lead to this condition, our findings show that the cellular metabolic response is the same in patients,” said Naviaux. “And interestingly, it’s chemically similar to the dauer state you see in some organisms, which kicks in when environmental stresses trigger a slow-down in metabolism to permit survival under conditions that might otherwise cause cell death. In CFS, this slow-down comes at the cost of long-term pain and disability.”<br />
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Naviaux said the findings show that CFS possesses an objectively identifiable chemical signature in both men and women and that targeted metabolomics, which provide direct small molecule information, can provide actionable treatment information. Only 25 percent of the metabolite disturbances found in each person were needed for the diagnosis of CFS. Roughly 75 percent of abnormalities were unique to each individual, which Naviaux said is useful in guiding personalized treatment.<br />
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“This work opens a fresh path to both understanding the biology of CFS and, more importantly to patients, a robust, rational way to develop new therapeutics for a disease sorely in need of them.”<br />
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The study authors noted additional research using larger groups of participants from diverse geographical areas is needed to validate both the universality and specificity of the findings.<br />
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Co-authors include: Jane C. Naviaux, Kefeng Li, A. Taylor Bright, William A. Alaynick, and Lin Wang, all at UC San Diego; and Asha Baxter, Neil Nathan, Wayne Anderson, and Eric Gordon, Gordon Medical Associates.<br />
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Funding for this research came, in part, from the UC San Diego Christini Fund, The Wright Family Foundation, The Lennox Foundation, the It Takes Guts Foundation, the UC San Diego Mitochondrial Disease Research Fund and gifts from Tom Eames and Tonye Marie Castenada.<br />
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For more information about CFS and mitochondrial research, visit <a href="http://naviauxlab.ucsd.edu/" target="_blank">naviauxlab.ucsd.edu</a><br />
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<b>Journal Reference</b>: Robert K. Naviaux, Jane C. Naviaux, Kefeng Li, A. Taylor Bright, William A. Alaynick, Lin Wang, Asha Baxter, Neil Nathan, Wayne Anderson, Eric Gordon. Metabolic features of chronic fatigue syndrome. <a href="http://www.pnas.org/content/early/2016/08/24/1607571113">Proceedings of the National Academy of Sciences</a>, 2016; 201607571 DOI: 10.1073/pnas.1607571113Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-17891730360089261482016-08-30T04:59:00.003-07:002016-08-30T04:59:47.654-07:00Urgent Call to Action! Support Congressional Call for Increased ME/CFS Research!<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhB5oI0ak7nTTsHWiitJOT1EoDc6C0hyphenhyphenHFQxzSu1AnNmE11drfMTvQwz4l31NY-uskQONHpyZTwWSrRMJupcM_iWJNrokB5UOfFnSXBj4rDS0UJ0u4GLdRNenYeMDcr3g76Ux1r2FsL_dI/s1600/congress.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="217" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhB5oI0ak7nTTsHWiitJOT1EoDc6C0hyphenhyphenHFQxzSu1AnNmE11drfMTvQwz4l31NY-uskQONHpyZTwWSrRMJupcM_iWJNrokB5UOfFnSXBj4rDS0UJ0u4GLdRNenYeMDcr3g76Ux1r2FsL_dI/s400/congress.jpg" width="400" /></a></div>
<span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">By Mass CFIDS/ME and FM Association</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">You can help if you ACT NOW !!</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">A letter in support of ME/CFS research to NIH Director Dr. Francis Collins, sponsored by two Representatives from California, is now circulating in Congress</strong><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"> (House of Representatives) and we need as many U.S. Representatives as we can to be co-signers. Please CALL and send a FOLLOW-UP EMAIL to your U.S. Representative (not your Senators) and urge him or her to sign this letter. Complete instructions, including a phone and email script which you can personalize, can be found </span><a data-cke-saved-href="http://www.meaction.net/2016/08/25/urgent-take-part-in-the-us-congressional-call-to-action/" href="http://www.meaction.net/2016/08/25/urgent-take-part-in-the-us-congressional-call-to-action/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank" title="Call your U.S. Representative now! Link opens in a new window.">here</a><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">. The number of calls to each Congressional office to make this request really matters. Your Representative may not be inclined to act as a result of one or two calls, but 10 calls will make a strong statement. </span><strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Please call right away. The deadline for your Representative to sign the letter is this coming Wednesday, August 31.</strong><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">This action is the result of months of hard work by #MEAction, Solve CFS/ME Initiative, and the U.S. Action Working Group Congressional Committee.</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br />
<h2 style="color: #222222; font-family: Arial, Verdana, sans-serif;">
GET and CBT have been downgraded as treatments for ME/CFS as a result of follow up work by the Agency for Healthcare Research and Quality.</h2>
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">In the initial Evidence Review prepared by AHRQ as input to the Pathways to Prevention (P2P) report commissioned by NIH, studies evaluating the effectiveness of Graded Exercise Therapy (GET) and Cognitive Behavioral Therapy (CBT) which used subjects meeting only the Oxford case definition (6 months of fatigue). Based on the initial inclusion of studies using the Oxford definition, notably the PACE trials, the Evidence Review suggested that GET and CBT were "moderately effective" treatments. The P2P report recommended that the Oxford definition no longer be used, and the PACE research has come under increasing criticism for its methodology.</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">As a result of advocates requests, AHRQ re-analyzed the evidence for GET and CBT, without including any studies based on the Oxford definition (e.g. PACE). The conclusion was that there was no evidence to suggest that GET or CBT were effective treatments for ME/CFS. </span><a data-cke-saved-href="http://occupyme.net/2016/08/16/ahrq-evidence-review-changes-its-conclusions/" href="http://occupyme.net/2016/08/16/ahrq-evidence-review-changes-its-conclusions/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank" title="GET and CBT are not effective treatments! Link opens in a new window.">Read more here</a><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">. </span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">This outcome is the direct result of repeated requests to AHRQ by advocates. Advocates' next step is to make sure that this change is strongly noted in future medical education materials, particularly the websites commonly used by doctors, such as the Centers for Disease Control and Prevention (CDC), Mayo Clinic and Up To Date.</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">You can find your congressional representative </span><a data-cke-saved-href="http://www.house.gov/representatives/find/" href="http://www.house.gov/representatives/find/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">HERE</a><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">.</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Email Template</em><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">:</span><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /><span style="background-color: white; color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Dear ___________ (name of representative goes here)</span><br />
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
<br />I’m emailing with an urgent request regarding the disabling neuro-immune disease Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome or ME/CFS.<br /></div>
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
Representatives Lofgren and Eshoo of California are sponsoring a letter to NIH Director Francis Collins in support of ME/CFS patients and research. ME/CFS costs the U.S. economy $17-24 billion annually; leaves its patients with lower quality of life scores than lung cancer, stroke, and rheumatoid arthritis; and has no known FDA-approved treatment or cure. Would you please support me and the 1 to 2.5 million Americans suffering from this disabling disease, by signing this letter? It would mean the world to me, my family, and other ME/CFS patients in our district to have your support.</div>
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
<br />Please contact Angela Ebiner, Legislative Assistant for Rep. Zoe Lofgren (CA-19) at Angela.Ebiner@mail.house.gov or (202) 225-3072 to coordinate your participation. The letter’s deadline is 8/31.</div>
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
<br />Thank you so very much for your support on this critical action. I look forward to your reply on this request at your earliest convenience.</div>
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
<br />Warmest Regards,<br /></div>
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
[Your Name]</div>
<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
[Your Contact Info, Including address and +4 zip]</div>
Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-50559401306918983032016-07-09T08:20:00.000-07:002016-07-09T16:28:39.730-07:00It's All in Your Gut<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjLiKvQKxA6GqpCQlIy9_1jF-Cyqsq-Cx8uITOYm33WXP5IGJcAgQTD3bnsAApPFmMKAI7cmJR6GX0rV0bdzJBY3RZgbhz6B2YtRnS8qkux3-1V-y1-dLQ2QRZz42A99vsrMLI-JrFc-ek/s1600/microbiome+mecfs.gif" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="317" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjLiKvQKxA6GqpCQlIy9_1jF-Cyqsq-Cx8uITOYm33WXP5IGJcAgQTD3bnsAApPFmMKAI7cmJR6GX0rV0bdzJBY3RZgbhz6B2YtRnS8qkux3-1V-y1-dLQ2QRZz42A99vsrMLI-JrFc-ek/s400/microbiome+mecfs.gif" width="400" /></a></div>
A study out of Cornell University made the news recently when Maureen Hanson's team found distinct alterations in the gut flora of patients with ME/CFS. The headlines trumpeted the "first" biological marker for the disease in the microbiome.<br />
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Those of us who have kept track of the research know that this is not a "first." De Meirleir, Maes, Lemle, as well as Dunstan, and Butt in Australia have all published papers documenting alterations in gut flora in patients with ME/CFS (not to mention Lipkin and Hornig's huge <a href="http://microbediscovery.org/" target="_blank">Microbe Discovery Project</a>). Those alterations laid the groundwork for Butt's successful treatment of ME with fecal transplants in the late 90s.<br />
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The question that needs to be asked is whether these alterations are the cause or the result of the disease. Every disease produces alterations in gut flora - diabetes, Crohn's, heart disease, HIV, and cancer are among them, as well as all infections. (For a good paper on this topic go <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425030/" target="_blank">HERE</a>.) The gut, which is the seat of your immune system, responds instantly to pathogens. It even changes in accord with what you are eating withing a few hours.<br />
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But rather than chicken or egg, these gut changes could be chicken <i>and</i> egg. For example, the pathogen that causes ME results in changes to the microbiome, then subsequent chronicity due to an altered immune system results in a perpetuation of microbiome changes. These, in turn, lead to more chronicity as commensal bacteria enter the bloodstream.<br />
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It's a good model, even if it doesn't identify the original culprit that started this chain of events.<br />
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<i>You can read the full study </i><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425030/" target="_blank">HERE</a>.<br />
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____________________________<br />
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<b>Key to chronic fatigue syndrome is in your gut, not head</b><br />
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By Melissa Osgood, <a href="http://mediarelations.cornell.edu/2016/06/27/3770/" target="_blank">Cornell University</a><br />
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Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn't alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.<br />
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Now, for the first time, Cornell University researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.<br />
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In a study published June 23 in the journal <i>Microbiome</i>, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.<br />
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"Our work demonstrates that the gut bacterial microbiome in chronic fatigue syndrome patients isn't normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease," said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics at Cornell and the paper's senior author. "Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin."<br />
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"In the future, we could see this technique as a complement to other noninvasive diagnoses, but if we have a better idea of what is going on with these gut microbes and patients, maybe clinicians could consider changing diets, using prebiotics such as dietary fibers or probiotics to help treat the disease," said Ludovic Giloteaux, a postdoctoral researcher and first author of the study.<br />
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In the study, Ithaca campus researchers collaborated with Dr. Susan Levine, an ME/CFS specialist in New York City, who recruited 48 people diagnosed with ME/CFS and 39 healthy controls to provide stool and blood samples.<br />
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The researchers sequenced regions of microbial DNA from the stool samples to identify different types of bacteria. Overall, the diversity of types of bacteria was greatly reduced and there were fewer bacterial species known to be anti-inflammatory in ME/CFS patients compared with healthy people, an observation also seen in people with Crohn's disease and ulcerative colitis.<br />
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At the same time, the researchers discovered specific markers of inflammation in the blood, likely due to a leaky gut from intestinal problems that allow bacteria to enter the blood, Giloteaux said.<br />
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Bacteria in the blood will trigger an immune response, which could worsen symptoms.<br />
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The researchers have no evidence to distinguish whether the altered gut microbiome is a cause or a whether it is a consequence of disease, Giloteaux added.<br />
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In the future, the research team will look for evidence of viruses and fungi in the gut, to see whether one of these or an association of these along with bacteria may be causing or contributing to the illness.<br />
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<b>Journal Reference</b>: Ludovic Giloteaux, Julia K. Goodrich, William A. Walters, Susan M. Levine, Ruth E. Ley, Maureen R. Hanson. Reduced diversity and altered composition of the gut microbiome in individuals with myalgic encephalomyelitis/chronic fatigue syndrome. Microbiome, 2016; 4 (1) DOI: <a href="http://10.0.4.162/s40168-016-0171-4" target="_blank">10.1186/s40168-016-0171-4</a><br />
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-72488622691382608222016-06-17T09:05:00.000-07:002016-06-17T09:05:48.405-07:00Chasing Competent Care Conference Report<div class="separator" style="clear: both; text-align: center;">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhrSFRHsVdbMZEkYWw26zMvi2tiMMZqTV2GvESt9Y67NuBhhMZcn0pRQD3WLUMqvsULIx6UTNiNnBcDVKlae2AooBJF3SF85KifL5OpqD0vagk-uRkyhNaZoYdtF2RhQ141q3FRqDZmDh4/s1600/Mady+Hornig+%25282%2529.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="267" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhrSFRHsVdbMZEkYWw26zMvi2tiMMZqTV2GvESt9Y67NuBhhMZcn0pRQD3WLUMqvsULIx6UTNiNnBcDVKlae2AooBJF3SF85KifL5OpqD0vagk-uRkyhNaZoYdtF2RhQ141q3FRqDZmDh4/s400/Mady+Hornig+%25282%2529.jpg" width="400" /></a></div>
By Sally Burch<br />
<br />
<div class="MsoNormal">
<span lang="EN-GB"><a href="http://www.hope4mefibroni.btck.co.uk/" target="_blank">Hope 4 ME & Fibro Northern Ireland</a> ran an ambitious and exciting conference
on Monday 6th June in The Stormont Hotel, Belfast. The conference, “Chasing Competent Care”
delivered a strong message calling for change to the currently inadequate care
situation for ME and fibromyalgia patients in Northern Ireland. </span></div>
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<span lang="EN-GB">Chairperson, Martina Marks opened the
meeting, welcomed everyone and thanked the Big Lottery Fund for their
sponsorship of the event. Her welcome was followed by an impassioned plea from
Joan McParland, the founder and treasurer of Hope 4 ME & Fibro NI, to have
medical professionals take patients’ symptoms seriously. Joan explained that she had been ill, and
operating at less than 30% of her normal capacity, since 1999. In that time no
effective treatments had been offered, and one consultant had even suggested
she was simply reading too much into her symptoms and that she should see a
psychiatrist!</span></div>
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<span lang="EN-GB">Joan thanked the many volunteers and family
members who made the event possible, and also the medical professionals and
MLAs in the audience for taking time to attend.</span></div>
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<span lang="EN-GB">Sally Burch, another charity trustee, then
pointed out that ME (myalgic encephalomyelitis) <a href="https://www.blogger.com/null" name="_GoBack"></a>and
fibromyalgia are both disorders recognised by the World Health Organisation.
She then explained that the most severely affected by ME could be left
bed-bound, tube fed and lying in darkened rooms for weeks, months and years!
She further described the severely debilitating nature of fibromyalgia and how
the invisible pain that sufferers endure can have devastating life
consequences. Sally outlined the symptom overlap between these conditions and
suggested that biomarker development and medical research was now urgently
required. </span></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4ht5vuU87tK_T1Z3unqYDceYAnX75t86cMH_1J7m2vKQtPrAe87SH-c69nmUw26R3eiklL-CCugZByWS1Xn8rSoIEoSOQ_vTtVG6PbmEsXKenLYbGeuyWDzVR4-RQN77uorEHzMLRHnE/s1600/shoes+ireland.JPG" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="221" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4ht5vuU87tK_T1Z3unqYDceYAnX75t86cMH_1J7m2vKQtPrAe87SH-c69nmUw26R3eiklL-CCugZByWS1Xn8rSoIEoSOQ_vTtVG6PbmEsXKenLYbGeuyWDzVR4-RQN77uorEHzMLRHnE/s400/shoes+ireland.JPG" width="400" /></a></div>
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<span lang="EN-GB">Lined up, to the side of the speakers’
podium, was a haunting display of over 200 pairs of empty shoes. These were
part of the global #MillionsMissing campaign. Each pair of shoes carried a tag
with the name of a patient unable to participate in their active lives due to
ME and/or fibromyalgia. During the
conference many attendees took time to read the comments on the tags and to
consider the magnitude of the devastation caused by these largely forgotten and
ignored conditions.</span></div>
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<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmR3b2PeujOGS3KfT_HhK51QkPTrUVkezOXX67UfREZ0r2O1_Wcq3BO_FcP8JrLWBuSXdcy9O8U9kzkMaaef3YY7yMJ2Y83wUHw7ziRPAB1ZiXYcFwzhLHdBPMAphp5Vzh1WhNh7Cvuag/s1600/Joe+McVeigh.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmR3b2PeujOGS3KfT_HhK51QkPTrUVkezOXX67UfREZ0r2O1_Wcq3BO_FcP8JrLWBuSXdcy9O8U9kzkMaaef3YY7yMJ2Y83wUHw7ziRPAB1ZiXYcFwzhLHdBPMAphp5Vzh1WhNh7Cvuag/s320/Joe+McVeigh.jpg" width="313" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><span style="font-size: small; text-align: start;">Joe McVeigh</span></td></tr>
</tbody></table>
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<span lang="EN-GB">First speaker up was Dr. Joe McVeigh, who
outlined the problems with exercise and fibromyalgia. He explained that whilst
exercise is important for maintaining health, that it must be conducted at a
level manageable for each individual patient. He called this the “Goldilocks
approach”, and explained that at no time should attempted exercise cause a
patient to relapse. </span></div>
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<span lang="EN-GB">Professor Malcolm Hooper next gave a strong
talk berating the inadequacies and misleading conclusions of the PACE
Trial. At one point, he suggested that
the PACE Trial was potentially fraudulent and told us that he had once even
said as much in The House of Lords. This
elicited a spontaneous round of applause from the audience. Feelings run high
amongst patients on the PACE trial, mostly because it has been used to support
the NHS recommended therapies of Cognitive Behaviour Therapy (CBT) and Graded
Exercise Therapy (GET), both of which have been demonstrated to cause harm in
patient surveys. </span></div>
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<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie8I0g34wuIzKw3HuDpoHD7rF3I_jnHOq4yJk2_1vSFTAuvTKUeFZsSwQK-f-1s42ALWnvKjBwzAclrhsjAN47RRtxTPt06M564yiDXEj2es0JxgugNRHEFeRKHYgdiaLqJqirTo8MnBg/s1600/malcolm+hooper.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="202" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie8I0g34wuIzKw3HuDpoHD7rF3I_jnHOq4yJk2_1vSFTAuvTKUeFZsSwQK-f-1s42ALWnvKjBwzAclrhsjAN47RRtxTPt06M564yiDXEj2es0JxgugNRHEFeRKHYgdiaLqJqirTo8MnBg/s400/malcolm+hooper.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Malcolm Hooper</td></tr>
</tbody></table>
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<span lang="EN-GB">Professor Hooper questioned the motives of
the PACE trial authors in promoting results that carry such marginal benefits
and such great potential risks. He recommended that patients reference Mark
Vink’s paper, “<a href="https://www.sciforschenonline.org/journals/neurology/article-data/JNNB-2-124/JNNB-2-124.pdf" target="_blank">The PACE Trial Invalidates the Use of Cognitive Behavioral andGraded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome:A Review</a>,” any time they were asked to undertake these therapies. </span></div>
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<div class="MsoNormal">
<span lang="EN-GB">After this lively and well received talk,
the conference paused for a comfort break. The weather was uncharacteristically
balmy for Northern Ireland, and some of the audience sat outside in the evening
sun as they contemplated the issues raised.</span></div>
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<br /></div>
<div class="MsoNormal">
<span lang="EN-GB">Natalie Boulton, carer to her daughter who
has severe ME, spoke next. She opened by
showing a clip from the video “Voices from the Shadows”, that gave the audience
a disturbing insight into the annihilation caused by very severe ME. Natalie told us she had recently followed up
with some of the patients from the video and found many of them had worsened,
and that both Emily Collingridge and Lyn Gilderdale had since died. She spoke
of the horror of the treatments doled out by psychiatrists who believed patients
to be faking their illness. Hers was a genuinely moving and sobering talk. </span></div>
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<div class="MsoNormal">
<span lang="EN-GB">Next Professor Mady Hornig from Columbia
University, USA, gave a detailed and highly informative account of her work
towards developing blood biomarkers. She
explained how immunity and gut microbiota can be linked to the brain, its
functioning and mood. She talked about
the epigenetic changes that can occur in the microbiome during a person’s
lifetime and the link to serotonin production. She also talked about measuring
blood molecules such as cytokines before and after an exercise challenge in ME
patients, and comparing these changes to healthy controls. These cytokines
being the most promising as potential biomarkers. Although much of what she
described cannot be simply summarised, the audience was left with a strong
feeling that Professor Hornig is now working determinedly to solve the
biochemical riddles produced by ME.</span></div>
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<br /></div>
<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: left; margin-right: 1em; text-align: left;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_09FXiMgl7Lz3kq77C3OT95vROaDiIxrx5jdOW5hy_JujH9tLGbUhXGJ-yA9W_vxh_DGWnQhPx7z_A0SL7DFedc1mffn0Pq-TYascy3hYD-iKuNrf6WvpLjChRGDGInDZkXfPI1ySngo/s1600/Pamela+Bell.jpg" imageanchor="1" style="clear: left; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="276" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_09FXiMgl7Lz3kq77C3OT95vROaDiIxrx5jdOW5hy_JujH9tLGbUhXGJ-yA9W_vxh_DGWnQhPx7z_A0SL7DFedc1mffn0Pq-TYascy3hYD-iKuNrf6WvpLjChRGDGInDZkXfPI1ySngo/s320/Pamela+Bell.jpg" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><span style="font-size: small; text-align: start;">Pamela Bell</span></td></tr>
</tbody></table>
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<span lang="EN-GB">Dr. Pamela Bell then took the podium to talk
about the problem with pain. Dr. Bell has worked extensively in the field of
pain, and is now chair of the Pain Alliance Northern Ireland. She emphasised
the widespread nature of chronic pain and its disabling effects, noting that
once pain becomes chronic it no longer serves a useful purpose in the body. She
recognised the difficulties with effectively treating ongoing pain and
explained that different types of pain needed different drug types to alleviate
symptoms. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="EN-GB">The final speaker of the evening was Louise
Skelly from the Patient and Client Council of Northern Ireland. She spoke of her frustration at trying to
bring about change to the current impasse with Health and Social Care Board in
Northern Ireland regarding the care on offer for ME and fibromyalgia patients.
She spoke of her determination to follow through with the campaign to improve
the situation, and of the great need of these neglected patient cohorts. </span></div>
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<br /></div>
<div class="MsoNormal">
<span lang="EN-GB">Martina Marks then brought the conference
to a close. Overall the atmosphere of the evening was one of both frustration,
and of optimism. Frustration that change seems to be taking so long to happen
and for the injustices that have occurred along the way, but also optimism that
things are starting gain momentum towards real medical advances for the future.
</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="EN-GB">As the hall emptied, the lines of lonely
shoes from the #MillionsMissing campaign were gathered up, their labels still
attached, and some-one was heard to say: “These are the folk we do all this
for, they will not be left forgotten any longer.”</span></div>
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<span lang="EN-GB"><br /></span></div>
<div class="MsoNormal">
<span lang="EN-GB">____________________</span></div>
<br />
Please consider using this link for all your online shopping and raise funds for <a href="http://www.hope4mefibroni.btck.co.uk/" target="_blank">Hope 4 ME & Fibro Northern Ireland</a> at NO charge to you!<br />
<div>
<br />
<a href="https://www.giveasyoulive.com/refer" target="_blank">https://www.giveasyoulive.com/refer</a></div>
Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-87224075055390260762016-06-03T10:37:00.001-07:002016-06-03T10:37:43.012-07:00#MillionsMissing: A Day of Global Protest<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEguXS38NFZqDaZOFMPLmSmCH_-FxC2TnkFS-_gqq4BSL8_EdRi6hMnAfkDXbvms3OrUT2SLRn2fQqdfTKc9bX7IvAOOJ4UpKPFZsqFiHyr2fS67uatCHMd3dCvYvc1SJ6Lng-kM9yeBMh4/s1600/millionsdc2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEguXS38NFZqDaZOFMPLmSmCH_-FxC2TnkFS-_gqq4BSL8_EdRi6hMnAfkDXbvms3OrUT2SLRn2fQqdfTKc9bX7IvAOOJ4UpKPFZsqFiHyr2fS67uatCHMd3dCvYvc1SJ6Lng-kM9yeBMh4/s1600/millionsdc2.jpg" /></a></div>
<span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"><br /></span>
<span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"><i>This post was originally published on <a href="http://www.prohealth.com/me-cfs/library/showarticle.cfm?libid=28988" target="_blank">ProHealth</a></i>.</span><br />
<span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"><br /></span>
<span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">By Erica Verrillo</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">On May 25, 2016, protesters all around the globe gathered to demand greater recognition and research funding for ME/CFS. Simultaneous protests were held in Melbourne, Australia; London, England; Belfast, Ireland, Ottawa, Canada; and in Boston, Washington, DC, Seattle, San Francisco, Dallas, Raleigh, Atlanta. and Philadelphia in the U.S. It was the largest protest ever held for this disease, involving thousands of participants worldwide.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">The Millions Missing protest was organized by MEAction and coordinated by a group of dedicated advocates in order to highlight the long neglect of patients with ME and CFS. Millions missing represents the missing millions of dollars of research funding that should have been spent to find a cause and a cure. Millions missing also represents the millions of people who are missing their careers, their families, their friends, and their lives due to the ravages of a disease that can disable a sufferer for decades.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">In most of these demonstrations, a display of shoes, sometimes in the hundreds, was laid out to symbolize missing patients who, due to illness, could not protest in person. Virtual demonstrations – pictures of shoes placed in driveways, on doorsteps, and on walkways accompanied by personal notes– were held in tandem. The virtual protest generated over 10,000 tweets with the hashtag #MillionsMissing as well as thousands of posts on Facebook.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">Local organizers took advantage of this event to schedule meetings with HHS officials as well as their representatives. Jennifer Brea, founder of #MEAction, met with Senator Cory Booker's staff (Dem NJ), and patient advocate Sonya Heller Iray met with Senator John McCain (Rep AZ) and his staff for an hour.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><em style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">To view photos from the #MillionsMissing protests around the world, go</em><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><a href="http://app.getresponse.com/click.html?x=a62b&lc=xXHAn&mc=II&s=SFhUn8&u=I3Kn&y=8&" rel="nofollow" style="background-color: white; color: #018fd0; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px; text-decoration: none;" target="_blank">here</a><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><em style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">The #MillionsMissing protest list of demands can be found</em><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><a href="http://app.getresponse.com/click.html?x=a62b&lc=xXmEH&mc=II&s=SFhUn8&u=I3Kn&y=I&" id="yui_3_16_0_ym19_1_1464434629198_2474" rel="nofollow" style="background-color: white; color: #018fd0; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px; text-decoration: none;" target="_blank"><span id="yui_3_16_0_ym19_1_1464434629198_2473">here</span></a><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><em style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">For #MillionsMissing in the news go <a href="http://www.meaction.net/2016/05/30/millionsmissing-in-the-news/" style="color: #018fd0; text-decoration: none;" target="_blank">here</a></em><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">. </span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><br />
<h2 style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-weight: normal; margin: 0px; padding: 0px; text-align: center;">
<strong>SAN FRANCISCO</strong></h2>
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<img alt="" src="http://www.prohealth.com/library/articleImages//2016-Q2/sfdemo.jpg" style="height: 255px; margin: 7px 5px; width: 500px;" /></div>
<span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;"> </span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">More than one hundred people gathered in front of the Federal Building in San Francisco. Carol Head, CEO of Solve ME/CFS Initiative, exhorted the federal government to live up to its promises. “We're all here today, because it's time for our government to increase funding and support for this disease,” she said. Ron Davis, scientific director of Open Medicine Foundation, talked about the research he is doing. “We are very close to finding a biomarker,” he said. “We do NOT want to wait another thirty years.” And as his wife, Janet Dafoe, spoke about their severely ill son, Whitney, the crowd chanted “Whitney ... Whitney ... Whitney...” bringing tears to her eyes.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br />
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<strong>BOSTON</strong></h2>
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<img alt="" src="http://www.prohealth.com/library/articleImages//2016-Q2/bostonprotestgroup.JPG" style="height: 375px; margin: 5px 7px; width: 500px;" /></div>
<br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">In Boston, demonstrators assembled at the JFK Federal Building. They handed out information and gathered signatures on a petition to support more funding for ME/CFS. Members of the group met separately with senior officials from the Boston branch of Health & Human Services to ask for their support. Charmian Proskauer, President of the Mass CFIDS/ME and FM Association was upbeat about the meeting. “They were very well informed, understood our issues, and asked great questions. We see this as the beginning of an on-going relationship,” she said.</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br />
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<strong>SEATTLE</strong></h2>
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<strong>ATLANTA</strong></h2>
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<strong>MELBOURNE, AUSTRALIA</strong></h2>
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<img alt="" src="http://www.prohealth.com/library/articleImages//2016-Q2/melbourne.jpg" style="height: 281px; margin: 5px 7px; width: 500px;" /></div>
<br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">In Melbourne, hundreds of shoes were placed on the lawn in front of the Victoria State Library. (Photo credit: Karyn Adams)</span><br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><br />
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<strong>LONDON, ENGLAND</strong></h2>
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<img alt="" src="http://www.prohealth.com/library/articleImages//2016-Q2/millionslondon.jpg" style="height: 375px; margin: 5px 7px; width: 500px;" /></div>
<br style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;" /><span style="background-color: white; color: #212222; font-family: arial, helvetica, verdana, sans-serif; font-size: 17.3333px;">In London, demonstrators held a silent protest at the Department of Health. Many stretched duct tape across their mouths to symbolize government neglect of ME/CFS patients. Ollie Cornes, a former software engineer, said, “The treatments the NHS provides are so ineffective as to be a waste of time and can be very harmful, which is why we are protesting at the Deptartment of Health.” Like so many other patients, Cornes was unable to attend the demonstration in person. He was represented by a pair of red baseball shoes.</span>Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-78758340885708550412016-05-12T05:56:00.002-07:002016-05-12T06:00:06.647-07:00This Is It! May 12th International ME/CFS Awareness Day!<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiMRwTkWWxZZm6mULtkCCWeJQ6VyLs6FjpgKBIBU3eMp_sgHBr0UHhigiX6cetYWG6TQIIvyxj_Lw5H5AiGb-DrVkdGPfyst6qcoZbjC1435CbGhMJAwTdBHVqW0E_ZUfp2Lu09HUe6ym4/s1600/may+12.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="221" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiMRwTkWWxZZm6mULtkCCWeJQ6VyLs6FjpgKBIBU3eMp_sgHBr0UHhigiX6cetYWG6TQIIvyxj_Lw5H5AiGb-DrVkdGPfyst6qcoZbjC1435CbGhMJAwTdBHVqW0E_ZUfp2Lu09HUe6ym4/s400/may+12.jpg" width="400" /></a></div>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"><i>A version of this post first appeared on <a href="http://www.prohealth.com/me-cfs/library/showarticle.cfm?libid=28862" target="_blank">ProHealth</a></i>.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">By Erica Verrillo</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">International ME/CFS Awareness Day was originated by Tom Hennessy, an ME patient and staunch advocate who testified at numerous national and international ME/CFS conferences and meetings. Tom chose May 12th as ME/CFS Awareness Day to commemorate the birth of the famous nurse, Florence Nightingale, who suffered from an ME/CFS-like illness. May 12 is also International Nurses Day.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Over the years May 12 has been expanded to include other neuro-immune illnesses that share many of the features of ME/CFS. At present May 12 includes Fibromyalgia (FM), Lyme disease, and Multiple Chemical Sensitivity (MCS). All of these illnesses employ May 12 as an opportunity to raise public awareness, to contact representatives for more research, and to promote fund-raising activities.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Although it is not formally recognized in the US, International ME/CFS and FM Awareness Day is observed worldwide.</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Simple things you can do</strong><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">:</span><br />
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<li>Wear a blue ribbon for ME/CFS, a purple ribbon for FM, or a green ribbon for Lyme disease and MCS.</li>
<li>Tweet on May 12. Add #may12th to your tweet.</li>
<li>If you have a blog or a Facebook page, post something. It can be as simple as an awareness image.</li>
<li>If you have some spare cash, donate to research efforts. Open Medicine Foundation is raising money for their <a data-cke-saved-href="http://www.openmedicinefoundation.org/the-end-mecfs-project/" href="http://www.openmedicinefoundation.org/the-end-mecfs-project/" target="_blank">End ME/CFS Project</a>.</li>
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">INTERNATIONAL</strong><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Light Up the Night Challenge</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">. “The challenge is to get as many buildings as possible in your country to light up with one of the 3 colours used on May 12th – blue (ME/CFS), purple (FM) or green (Lyme and MCS). We want public buildings/places like City Halls, Niagara Falls and we want individual homes lit up too!” See the Facebook page </span><a data-cke-saved-href="https://www.facebook.com/events/1514264558796071/" href="https://www.facebook.com/events/1514264558796071/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">HERE</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">.</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">#May12BlogBomb is back!</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> May 12th is Awareness Day for ME, Fibromyalgia, Lyme Disease, Chronic Fatigue Syndrome and Multiple Chemical Sensitivity. Every year bloggers use this opportunity to express their views and to raise the profile of these much misunderstood and often maligned conditions. Blog bomb information is </span><a data-cke-saved-href="http://sallyjustme.blogspot.ca/2016/04/may12blogbomb-please-submit-your-links.html" href="http://sallyjustme.blogspot.ca/2016/04/may12blogbomb-please-submit-your-links.html" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">HERE</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">.</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Google – Create a Doodle</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">. Every year the doodlers ask Google to create a doodle. This year they are also supporting other events and activities. Please go to their Facebook page </span><a data-cke-saved-href="https://www.facebook.com/GoogleDoodle4May12th" href="https://www.facebook.com/GoogleDoodle4May12th" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">HERE</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">.</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">One week about ME on social media</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> This is where people with ME are asked to share one picture a day about their ME during ME awareness week. Each day has a specific photo topic: smile for ME, your favourite low level activity, something which makes you feel better, get creative with spoons, something you're preparing for, a hand written message to fellow spoonies, you on a good day. There are also a topic to write about each day alongside your photo for example "I wish people without ME would..." The photos are to be shared on social media using the hashtag #1weekaboutME.</span><br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgm3CgpsQKxNLW8VtADZ0xEz1prg8qj_7K3iAKGl7Z0Dj3vietBLB58qTS3rhQzaiwqkCI3Zq4lmDRDllkzA0nUj-k26sULxzZ82dHJsOSBpKO8uNUTMUSHm9bB2bbHNq8m1ZP4cmGz9ZI/s1600/weekaboutME-1024x1024.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgm3CgpsQKxNLW8VtADZ0xEz1prg8qj_7K3iAKGl7Z0Dj3vietBLB58qTS3rhQzaiwqkCI3Zq4lmDRDllkzA0nUj-k26sULxzZ82dHJsOSBpKO8uNUTMUSHm9bB2bbHNq8m1ZP4cmGz9ZI/s320/weekaboutME-1024x1024.jpg" width="320" /></a></div>
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<span style="color: brown; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"><strong>ME/CFS EVENTS</strong></span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><a data-cke-saved-href="http://millionsmissing.meaction.net/virtual/" href="http://millionsmissing.meaction.net/virtual/" target="_blank">#Millionsmissing Virtual Protest</a> – May 25</strong><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">The #Millionsmissing protest is being organized by ME Action to draw attention to the plight of millions of people with ME/CFS. There are several things you can do to participate in #Milllionsmissing that do not require leaving your home.</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">1. You can send your shoes to Washington DC</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">ME Action is asking patients who are unable to make it to the physical protest locations to please donate one pair of shoes. They will display them at the Washington, DC protest. You can send a pair of old shoes or if it’s difficult to get to the post office, order shoes on Amazon or Ebay and have them shipped directly. During the protest, images of these shoes will be posted to #MEAction’s social media account using the #MillionsMissing hashtag, so patients can see that they are being represented during the demonstration. Shoes cannot be returned. After the protest, they will be donated to a local charity or kept for a future installation.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Fill out </span><a data-cke-saved-href="https://docs.google.com/forms/d/1bIx2nQbemkFtd2Ryv_Jiz29-NCFDiIKVNoGwPVip0H4/viewform?c=0&w=1" href="https://docs.google.com/forms/d/1bIx2nQbemkFtd2Ryv_Jiz29-NCFDiIKVNoGwPVip0H4/viewform?c=0&w=1" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">this form</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> and and then mail your shoes to: Paige Maxon, P.O. Box 26051, Winston Salem, NC 27114. All shoes must be postmarked by May 10th, 2016!</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Send your shoes to London</strong><br />
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You can also send shoes to the London protest. Fill out this <a data-cke-saved-href="https://docs.google.com/forms/d/1JIa3dyCm_7UudCN3Ks2kHNn-o6HWuUeRTEQC3CA7TLw/viewform" href="https://docs.google.com/forms/d/1JIa3dyCm_7UudCN3Ks2kHNn-o6HWuUeRTEQC3CA7TLw/viewform" target="_blank">UK form </a>and mail to: LA Cooper, 25 Grassmead, Thatcham, Berkshire, RG19 4FP (UK)</div>
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Better yet – send to BOTH locations </span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">2. You can also put a pair of shoes at the end of your driveway or your doorstep.</em><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">On May 25th, take a pair of shoes (or several) and put them on your doorstep, lawn, or driveway. Take a photo and post it on social media #MillionsMissing. Anyone can participate. You might pair the shoes with a sign that expresses what the empty shoes mean to you. Some examples: “I cannot walk to the end of my driveway” or “My brother should be here.”</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">3. Use social media</em><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">On May 25th, post selfies on social media (Twitter, Facebook, Instagram, etc) – in your bed, home, wheelchair, at work, wherever you live – to help us show online the millions who are missing from the protest. Use the hashtag: #MillionsMissing so that we can aggregate all the photos. You can use #MEAction #mecfs #pwme to help identify your post.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">You can hold your own #Missingmillions protest sign with a slogan in your photo. Here are a few examples to get started:</span><br />
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<li>Missing my life for 22 years because of ME</li>
<li>Missing sufficient research</li>
<li>Missing adequate medical care</li>
<li>Missing a doctor who believes me</li>
<li>Missing college / Missing my family / Missing running in the park</li>
</ul>
<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">4. Promote #Missingmillions</em><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Promote the hashtag and shoe installation on your social media accounts. Email patients, friends, families, allies who are in the vicinity of the satellite protests </span><u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><a data-cke-saved-href="http://millionsmissing.meaction.net/locations/" href="http://millionsmissing.meaction.net/locations/">http://millionsmissing.meaction.net/locations/</a></u><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">5. If you are in the US, send an informational packet to your representatives</em><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Send this </span><a data-cke-saved-href="http://www.forgottenplague.com/product/congressional-pack/" href="http://www.forgottenplague.com/product/congressional-pack/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">Forgotten Plague Congressional Pack</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> to your congressmen/women and state representatives before the protest.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Find your congressional representative here: </span><u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><a data-cke-saved-href="http://www.house.gov/representatives/find/" href="http://www.house.gov/representatives/find/">http://www.house.gov/representatives/find/</a></u><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Find your Senator here: </span><u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><a data-cke-saved-href="http://www.senate.gov/senators/contact/" href="http://www.senate.gov/senators/contact/">http://www.senate.gov/senators/contact/</a></u><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Detroit, Michigan</strong><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">New organization FIND (Foundation for Immunological and Neurological Diseases) will be hosting an</span><br />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">ME/CFS Awareness Walk 2016 - May 14, in Troy, Michigan (Detroit area), contact Frank Plizga - </span><a data-cke-saved-href="mailto:sicnar@comcast.net" href="mailto:sicnar@comcast.net" id="yui_3_16_0_ym19_1_1462491770918_3293" rel="nofollow" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank" ymailto="mailto:sicnar@comcast.net">sicnar@comcast.net</a><br />
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<a data-cke-saved-href="http://www.meadvocacy.org/r?u=https%3A%2F%2Fwww.facebook.com%2Fevents%2F227053180988355%2F&e=6a7f1462899e9c84f35ce1c30139c91a&utm_source=meadvocacy&utm_medium=email&utm_campaign=find_walk_2016&n=2" href="http://www.meadvocacy.org/r?u=https%3A%2F%2Fwww.facebook.com%2Fevents%2F227053180988355%2F&e=6a7f1462899e9c84f35ce1c30139c91a&utm_source=meadvocacy&utm_medium=email&utm_campaign=find_walk_2016&n=2" id="yui_3_16_0_ym19_1_1462491770918_3292" rel="nofollow" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">https://www.facebook.com/events/227053180988355/</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">The walk is from noon to 1 pm. So there are 5 confirmed walkers and 5 conditional. There will be balloons, signs and passouts.</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Fundraising</strong><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><a data-cke-saved-href="http://www.undiesontheoutside.org/#!do-the-challenge/bsbe2" href="http://www.undiesontheoutside.org/#!do-the-challenge/bsbe2" target="_blank">Undies on the Outside Challenge</a></strong></div>
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Help raise funds for OMF's End ME/CFS Project! WHY UNDIES ON THE OUTSIDE? Because superheroes wear their undies on the outside, and you have to be a superhero to live with this disease! Wearing underwear on the outside symbolizes bringing an invisible illness, which is usually hidden away, out into the open.</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">AUSTRALIA</strong><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">The </span><a data-cke-saved-href="http://emerge.org.au/do-something-for-me/?utm_source=Emerge+Australia+news&utm_campaign=71eb779ac1-March_newsletter1_30_2015&utm_medium=email&utm_term=0_cb6be2bd74-71eb779ac1-128486865&ct=t(April_newsletter1_30_2015)" href="http://emerge.org.au/do-something-for-me/?utm_source=Emerge+Australia+news&utm_campaign=71eb779ac1-March_newsletter1_30_2015&utm_medium=email&utm_term=0_cb6be2bd74-71eb779ac1-128486865&ct=t(April_newsletter1_30_2015)" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">Do Something for ME</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> project is designed to raise awareness in the general community about ME/CFS and to raise funds to support Emerge Australia to continue its work advocating for, educating about and providing information on the condition.</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">IRELAND</strong><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Walk for ME</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> is a 5 km Charity Walk to raise Awareness and Funding for biomedical research into M.E. (Myalgic Encephalomyelitis) at the beautiful </span><a data-cke-saved-href="http://www.belvedere-house.ie/" href="http://www.belvedere-house.ie/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">Belevedere House & Gardens</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">. All proceeds going directly to the charity "Invest In ME" for biomedical research into M.E. “We're not strict on people finishing the full 5 km, if they're not able. A person can undertake any amount of distance.” For more information go </span><a data-cke-saved-href="https://www.facebook.com/events/1100549473328563/" href="https://www.facebook.com/events/1100549473328563/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">HERE</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">.</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">The Irish ME/CFS Association</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> is pleased to announce that it has arranged for four free screenings of the documentary on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Forgotten Plague, in various venues around Ireland during May, ME/CFS Awareness Month: </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">- Limerick: South Court Hotel. Thurs, May 5. 11:30 AM. </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">- Galway: Maldron Hotel, Headford Road. Thurs, May 12. 7.30pm </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">- Dundalk: An Táin Theatre, Crowe Street. Tues, May 17. 2 PM. </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">- Dublin: Crowne Plaza Dublin Blanchardstown. Sunday, May 29. 3 PM. </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">These are the first public screenings of the documentary in Ireland. </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">All are welcome. Further details are available on the Association’s website </span><a data-cke-saved-href="http://www.irishmecfs.org" href="http://www.irishmecfs.org/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">www.irishmecfs.org</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">. </span><br />
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<strong>UK</strong></div>
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Please come support our #MillionsMissing UK Protest in London!</h4>
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">When:</strong><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> Wed. May 25th, 2016 12 PM – 2PM</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Where:</strong><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> Department of Health Richmond House</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">79 Whitehall, London SW1A 2NS, United Kingdom</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Be a part of the #MillionsMissing international day of protest, by attending #MillionsMissing UK, either physically or virtually. Come stand for the millions of severely ill patients living with this ME/CFS who are missing out on every day life. Whether you’re a patient, healthy ally or someone just learning of this disease, everyone is welcome to join in the fight for more funding for research and education.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To be at the protest in London, we suggest you bring a blanket, pillow, mobility scooter, or wheelchair to be as comfortable as possible. Consider wearing duct tape, with #MillionsMissing written across to represent this silent epidemic.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To particiapte virtually, please send shoes to the </span><a data-cke-saved-href="http://millionsmissing.meaction.net/virtual/" href="http://millionsmissing.meaction.net/virtual/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">#MillionsMissing DC Protest</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> or the #MillionsMissing UK Protest. To send shoes to the UK Protest, please mail to: 25 Grassmead, Thatcham, Berkshire, RG19 4FP (UK) </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Email L.A. Cooper with any questions at info@changeformechangeforus.co.uk</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Blue Sunday</strong><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">When</strong><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">: May 15</span><br />
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Where</strong><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">: UK</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Blue Sunday is an event which has been going on for several years. Anna, the organiser invites you to have a coffee morning with your friends and family in aid of the ME Association. Guests are asked to bring the amount of money they would normally expect to pay for tea and cake as a donation. You can also take part in the national movement online, by joining in virtually! Here is a </span><a data-cke-saved-href="http://lifeintheslowlanewithme.blogspot.co.uk/2016/04/another-year-another-fundraiser.html" href="http://lifeintheslowlanewithme.blogspot.co.uk/2016/04/another-year-another-fundraiser.html" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">link to a blog post</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> where Anna talks about the event in more detail, and here is a </span><a data-cke-saved-href="https://www.facebook.com/events/168427933537464/" href="https://www.facebook.com/events/168427933537464/" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">link to the online event</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">, for those who are unable to attend an event or host their own. Here is </span><a data-cke-saved-href="https://www.justgiving.com/teams/BlueSunday2016" href="https://www.justgiving.com/teams/BlueSunday2016" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">a fundraising page</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">, where you can join the team, or donate to a member of the team! You can read about the </span><a data-cke-saved-href="http://lifeintheslowlanewithme.blogspot.co.uk/p/blue-sunday.html" href="http://lifeintheslowlanewithme.blogspot.co.uk/p/blue-sunday.html" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;" target="_blank">history of the event here</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">.</span><br />
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<strong>Go blue for ME</strong><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">This is organized by the ME Association, as blue is the color for ME awareness the public are encouraged to dress up in blue, or do something related to the color blue for ME awareness day which is the 12th of may, or for ME awareness week which is the 9th-15th of May. Share your blue antics on social media using the hashtags #GoBLUEME, #MEawareness or #MEawarenessweek! See the image below for more details.</span></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgW67ltG9kOzWkwiBeLw6IAmnE-8MHUOW_5XQdf2t-E1OcTfRaElkhyphenhyphenC65F5pKMtyU7KbVETBCDni5M4yjfSY7RRbHB5GzTTbSVupL2B8EN0gtgwW8-4vKINgfrsu6_1zeh_bSfDCwP9-A/s1600/goblue.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgW67ltG9kOzWkwiBeLw6IAmnE-8MHUOW_5XQdf2t-E1OcTfRaElkhyphenhyphenC65F5pKMtyU7KbVETBCDni5M4yjfSY7RRbHB5GzTTbSVupL2B8EN0gtgwW8-4vKINgfrsu6_1zeh_bSfDCwP9-A/s320/goblue.jpg" width="227" /></a></div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-82172555055158438572016-05-10T04:32:00.001-07:002016-05-10T04:41:07.481-07:00#MillionsMissing ME/CFS Protest: Demands<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgr15MYqoCRWLPUBsXAb3nbERVIIPvfZdvXMopZ3EQiwWFt7zAqXbYsqffV0fPCkeEN5pjMQJSSvGQGjcMsAjEC185GU7nfLpe-d9MdW7aKk1IK7sxKqYJxVR1rmt9JuvgLqvbPq0hnz4Oe/s1600/millionsmissing.png" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="267" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgr15MYqoCRWLPUBsXAb3nbERVIIPvfZdvXMopZ3EQiwWFt7zAqXbYsqffV0fPCkeEN5pjMQJSSvGQGjcMsAjEC185GU7nfLpe-d9MdW7aKk1IK7sxKqYJxVR1rmt9JuvgLqvbPq0hnz4Oe/s400/millionsmissing.png" width="400" /></a><em>Reprinted with permission from <a data-cke-saved-href="http://www.meaction.net/2016/05/01/millionsmissings-protest-demands-available/" href="http://www.meaction.net/2016/05/01/millionsmissings-protest-demands-available/" target="_blank">ME Action</a></em>.</div>
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">On May 25, 2016, at the #MillionsMissing demonstrations, Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) patients and families, advocacy organizations and individual activists call for the US Department of Health and Human Services to implement the following list of demands.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Our goal is to give the 1 to 2.5 million[i] disabled American ME/CFS patients their lives back, and to prevent even more children, teens, young adults and adults from joining the ranks of the millions who are already missing — missing from their careers, schools, social lives and families due to the debilitating symptoms of the disease. </span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Millions of dollars are also missing from ME/CFS research, and millions of medical providers are missing out on proper clinical training to diagnose and help patients manage this devastating illness.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">For ME/CFS patients and their families, we demand:</span><br />
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<li><strong>Increased Funding and Program Investments</strong></li>
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Funding and program investments commensurate with the disease burden</span><br />
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<li value="2"><strong> Clinical Trials</strong></li>
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Clinical trials to secure medical treatments for ME/CFS</span><br />
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<li value="3"><strong> Accurate Medical Education</strong></li>
</ol>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Replacement of misinformation with accurate medical education and clinical guidelines</span><br />
<ol style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li value="4"><strong> A Serious Commitment</strong></li>
</ol>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">HHS leadership, oversight and a serious commitment to urgently address ME/CFS</span><br />
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<div style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">
<strong>Rationale and Details </strong><strong>for the #MillionsMissing ME/CFS Protest Demands</strong></div>
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<strong><br /></strong></div>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">For ME/CFS patients and their families, we demand:</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">1. <u>Funding and Program Investments Commensurate with the Disease Burden</u></strong><br />
<b><u><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /></u></b><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">The NIH must dedicate funding and program investments for ME/CFS commensurate with the disease burden, and they must do this without continued delay, as patients have already been waiting three decades.</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Rationale</u><br />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><br /></u>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Thirty years of neglect by the NIH, combined with a stigma toward this disease, has resulted in insufficient and erroneous research as well as uninvolved academic researchers and pharmaceutical companies. </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To address these problems, and save lives, the NIH must </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">immediately implement an aggressive set of investments to substantially ramp up its funding and program commitments over the next 3-5 years.</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Details</u><br />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><br /></u>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To finally have NIH funding and investments commensurate with disease burden, our demand is to increase the paltry $7M per year currently allotted to ME/CFS </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">to the more equitable amount of $250M. This new program of investments must be developed and executed in collaboration with ME research experts, clinicians and patients, and must include:</span><br />
<ul style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li>Funding five regional ME/CFS Centers of Excellence, each with a research/clinical trial component and also a clinical care component to address the current crisis.</li>
<li>Funding multiple requests for applications (RFAs) for ME/CFS over the next three years, for a total of $10M the first year, $20M the second year and $25M the third year.</li>
<li>A significant increase in funding for investigator-initiated extramural research (including hypothesis-generating research), as well as a commitment of intramural staff focused on ME research.</li>
<li>Funding a research network that will collaborate in the development and execution of an ME/CFS research strategy.</li>
<li>Funding an outreach plan to engage major academic centers and pharmaceutical and biotech companies in ME/CFS research and drug development.</li>
</ul>
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">2. <u>Clinical Trials to Secure Medical Treatments for ME/CFS</u></strong><br />
<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><u><br /></u></strong>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">HHS must fund and incentivize ME/CFS clinical trials to secure medical treatments for ME/CFS. This must be done with great haste, as patients are missing out on their lives and losing their lives to this disease.</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Rationale</u><br />
<u><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /></u><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">After thirty years, there is still not one Food and Drug Administration (FDA)-approved medication for the disease. An estimated one-quarter of ME/CFS patients are severely ill, meaning at least two hundred and fifty thousand patients are unable to leave their homes or bed, many for decades. With no FDA-approved treatments available to them, they have little hope of ever improving. To address this situation, HHS must fund and incentivize clinical trials in the following manner:</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Details</u><br />
<ul style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li>We demand the NIH immediately partner with the FDA to address the key obstacles to moving clinical trials forward. NIH must also actively incentivize pharmaceutical and biotech industries so that at least five accelerated clinical trials of medications are conducted over the next five years. The goal must be getting at least two FDA-approved medications on the market for ME/CFS patients in the next five years. Proposed medications include Ampligen, Rituxan and antiviral medications, all drugs that have been in trials already and have been successfully used to treat ME/CFS patients.</li>
<li>The clinical trials must include severely ill, homebound patients, and must be overseen by an advisory team of ME/CFS specialists and researchers who best know the needs of this patient population.</li>
</ul>
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">3. </strong><strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><u>Accurate Medical Education and Clinical Guidelines</u></strong><br />
<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><u><br /></u></strong>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">The Centers for Disease Control and Prevention (CDC) must immediately discard its erroneous and outdated information related to ME/CFS and replace it with accurate medical education and clinical guidelines. The guidelines must be based on the most recent scientific information and the practices of ME/CFS experts, and be preapproved by a panel of recognized disease experts.</span><br />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"><br /></span>
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Rationale</u><br />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><br /></u>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">It is morally reprehensible and medically unethical for the CDC to continue to disseminate erroneous and outdated information that can hurt patients. In spite of the findings of the 2015 Institute of Medicine (IOM) report, the CDC still includes references to psychological theories and treatments, such as GET (graded exercise therapy) and CBT (cognitive behavior therapy), even though the IOM report discredits the idea that this disease is psychological. This perpetuates medical confusion and puts ME/CFS patients at significant risk of harm. To address this situation, the CDC must immediately issue new ME/CFS medical education and clinical guidelines in the following manner:</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Details</u><br />
<ul style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li>The CDC must immediately revise their ME/CFS medical education and clinical guidelines to replace erroneous and outdated information with updated, correct information based on the 2014 IACFS/ME Primer, and the IOM report, supplemented with the August 2015 recommendations from the CFS Advisory Committee. The IOM report stated that ME/CFS is not a psychological disease, yet much of the influential research on ME/CFS has focused on psychological factors. A 2015 NIH Pathways to Prevention (P2P) Report called for the retirement of the Oxford case definition because it is overly broad and includes people with other conditions including mental illness. Yet findings using the Oxford case definition are still being referenced in CDC material, even in new medical education information from the CDC and other medical education providers. This encourages an unethical focus on psychological factors and treatments, such as GET and CBT.</li>
<li>All medical education content must be approved by recognized ME/CFS expert clinicians, researchers and patients before publication.</li>
<li>The CDC must actively reach out to the larger medical community and to medical education providers to disseminate this updated content while simultaneously removing the erroneous information and material.</li>
</ul>
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<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">4.<u> HHS Leadership, Oversight and a Serious Commitment to Urgently Address ME/CFS</u></strong><br />
<strong style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><u><br /></u></strong>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">HHS must demonstrate a serious commitment to ME/CFS commensurate with the severity and prevalence of the disease. This commitment must specifically remove all internal HHS </span><span style="background-color: white; color: #222222; font-family: arial, verdana, sans-serif; font-size: 12px;">impediments to achieving rapid progress and must be implemented with the full and open collaboration of, and accountability to ME/CFS experts and patients.</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Rationale</u><br />
<u><br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" /></u><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">HHS’s lack of leadership and commitment to ME/CFS for the past thirty years has resulted in the neglect of a serious neurological disease and the abandonment of 1 to 2.5 million disabled Americans. HHS’s neglect has stalled research and drug development; disincentivized academic centers and pharmaceutical companies; and led to disbelieving medical providers, which has, in turn, resulted in a stigmatization of patients and abysmal, often harmful, clinical care. </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">HHS’s short-sighted policies and unilateral actions have destroyed the scientific and medical infrastructure for ME/CFS that could have advanced research and proper care for patients. </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">HHS must now act with a commitment, focus and sense of urgency regarding all aspects of its response to this disease in order to remedy the situation, as patients are losing their lives to this disease, many having spent years, even decades, too weak to function. In doing so, HHS’s decision-making process can no longer take place behind closed doors; HHS plans for ME/CFS must be developed and executed in conjunction with those who intimately know the disease: ME/CFS experts and patients.</span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Details</u><br />
<ul style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li>HHS Leadership, Oversight and Commitment</li>
</ul>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To ensure rapid progress, HHS must immediately accept the CFSAC Aug. 2015 recommendation of appointing a “senior-level cross-agency leader (“czar”) with the authority, position and fiscal responsibility required to coordinate, develop, implement, and monitor a broad strategic cross-agency response to this disease through open and collaborative engagement of both internal and external stakeholders.” </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">The plan must be fast-tracked and must include long-term goals and milestones, as well as criteria for measuring progress. The currently established Trans-NIH ME/CFS Working Group does not address these needs, as it has no coordination of a cross-agency strategic response. That response must address not only research, but also drug development, epidemiology, medical education, access and quality of medical care and public awareness.</span><br />
<ul style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li>NIH Leadership, Oversight and Commitment</li>
</ul>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Given the multi-systemic nature of ME/CFS, it is crucial that each relevant Institute within the NIH must immediately put forth its own publicly-stated strategic and financial commitments and goals. To ensure coordination across the Institutes and to make rapid progress on an NIH research strategy, the Trans-NIH ME/CFS Working Group must continue. Finally, to ensure we make fast progress in the context of the NIH’s organizational structure, ME/CFS must be assigned to an NIH Institute right away. Given ME’s clear neurological dysfunction, the disease must be placed in the National Institute of Neurological Disorders and Stroke (NINDS) as recommended by CFSAC. </span><br />
<ul style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px; padding: 0px 40px;">
<li>CDC Leadership, Oversight and Commitment</li>
</ul>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To demonstrate their serious commitment to urgently address ME/CFS, the CDC must restore the ME/CFS budget which was eliminated in their 2017 budget justification submitted to Congress. </span><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> Additionally, the CDC must provide funds to conduct epidemiological studies to reassess prevalence, prognosis and risk factors. In doing so, the CDC must use the Canadian </span><em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Consensus Criteria</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">, as does the NIH in its current intramural study. Further, the CDC must implement a mechanism to ensure that a panel of recognized disease experts are involved in final decision making on all aspects of the CDC’s efforts related to ME/CFS.</span><br />
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<em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Closing Note: These demands could change if there is any new information coming from the NIH, the CDC or HHS before the date of the #MillionsMissing demonstration on May 25, 2016.</em><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Contact</span><br />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">To learn more, please contact</span><br />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">info@MEAction.net</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">###</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015.</span><a data-cke-saved-href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;"> http://www.iom.edu/Reports/2015/ME-CFS.aspx</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015. </span><a data-cke-saved-href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;"> http://www.iom.edu/Reports/2015/ME-CFS.aspx</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">; </span><br />
<br style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;" />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">2015 Pathways to Prevention Report </span><a data-cke-saved-href="http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf" href="http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf</a><br />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">NIH Funding for Research by Disease. </span><a data-cke-saved-href="https://report.nih.gov/categorical_spending.aspx" href="https://report.nih.gov/categorical_spending.aspx" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">https://report.nih.gov/categorical_spending.aspx</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Mitchell WM, “Efficacy of rintatolimod in the treatment of chronic fatigue syndrome/ myalgic encephalomyelitis (cuffs/me).” </span><em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Expert Review of Clinical Pharmacology</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">. April 2016.</span><u style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;"><a data-cke-saved-href="http://www.ncbi.nlm.nih.gov/pubmed/27045557" href="http://www.ncbi.nlm.nih.gov/pubmed/27045557">http://www.ncbi.nlm.nih.gov/pubmed/27045557</a></u><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss H, Dahl O, Nyland H, Mella O. “Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study.” </span><em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Plos One</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> Oct 2011; 6(10): e26358.</span><a data-cke-saved-href="http://dx.doi.org/10.1371/journal.pone.0026358" href="http://dx.doi.org/10.1371/journal.pone.0026358" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://dx.doi.org/10.1371/journal.pone.0026358</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Montoya M, Kogelnik A, Bhangoo M, Lunn M, Flamand L, Merrihew, Watt T, Kubo J, Paik J, Desa M. “Randomized Clinical Trial to Evaluate the Efficacy and Safety of Valganciclovir in a Subset of Patients With Chronic Fatigue Syndrome.” </span><em style="color: #222222; font-family: Arial, Verdana, sans-serif; font-size: 12px;">Journal of Medical Virology</em><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> August 19, 2013. 85:2101–2109</span><a data-cke-saved-href="http://dx.doi.org/10.1002/jmv.23713" href="http://dx.doi.org/10.1002/jmv.23713" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://dx.doi.org/10.1002/jmv.23713</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. “Chronic Fatigue Syndrome Myalgic Encephalomyelitis: A Primer for Clinical Practitioners 2014 Edition.” 2012, revised 2014.</span><a data-cke-saved-href="http://www.iacfsme.org/LinkClick.aspx?fileticket=iD3JkZAZhts%3d&tabid=509" href="http://www.iacfsme.org/LinkClick.aspx?fileticket=iD3JkZAZhts%3d&tabid=509" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://www.iacfsme.org/LinkClick.aspx?fileticket=iD3JkZAZhts%3d&tabid=509</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015 .</span><a data-cke-saved-href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;"> http://www.iom.edu/Reports/2015/ME-CFS.aspx</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">2015 Pathways to Prevention Report – Page 16 </span><a data-cke-saved-href="http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf" href="http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf</a> <br />
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"><br /></span>
<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015 </span><a data-cke-saved-href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" href="http://www.iom.edu/Reports/2015/ME-CFS.aspx" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://www.iom.edu/Reports/2015/ME-CFS.aspx</a><span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;"> Page 1-3, 15-16, 27-31.</span><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">U.S. National Institutes of Health. Office of Disease Prevention. “Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. December 9-10, 2014. Executive Summary.” National Institutes of Health. Office of Disease Prevention. Final Report June 16, 2015 </span><a data-cke-saved-href="http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf" href="http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">U.S. Department of Health and Human Services CFS Advisory Committee. Advisory Committee Meeting Recommendations. August 18-19, 2015. Last accessed September 12, 2015 </span><a data-cke-saved-href="http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf" href="http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">U.S. Department of Health and Human Services CFS Advisory Committee. Advisory Committee Meeting Recommendations. August 18-19, 2015. Last accessed September 12, 2015 </span><a data-cke-saved-href="http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf" href="http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf</a><br />
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<span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Centers for Disease Control and Prevention. Justifications of Estimates for Appropriations Committees. Fiscal Year 2017. </span><a data-cke-saved-href="http://www.cdc.gov/budget/documents/fy2017/fy-2017-cdc-congressional-justification.pdf" href="http://www.cdc.gov/budget/documents/fy2017/fy-2017-cdc-congressional-justification.pdf" style="font-family: Arial, Verdana, sans-serif; font-size: 12px;">http://www.cdc.gov/budget/documents/fy2017/fy-2017-cdc-congressional-justification.pdf</a> <span style="background-color: white; color: #222222; font-family: "arial" , "verdana" , sans-serif; font-size: 12px;">Page 15.</span>Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-46985149686297114432016-05-06T03:38:00.000-07:002016-05-06T03:38:31.076-07:00Patients with Chronic Illness Rally to Raise Funds, Awareness, and Hope<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgH-TvtpdE2THRP6XUzX8a9TRnpSJKVNMwXxK9FcrhKok4inVkjSJDFyF1RwF8ZCmCRbWo4_mUcPlDPE5JF3hnY3FRVzSXq5s0ebnvbWwtf4KjqDKgs5HCFEiXfLqhW4DNFOtXmWo7qm-c/s1600/shoes.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgH-TvtpdE2THRP6XUzX8a9TRnpSJKVNMwXxK9FcrhKok4inVkjSJDFyF1RwF8ZCmCRbWo4_mUcPlDPE5JF3hnY3FRVzSXq5s0ebnvbWwtf4KjqDKgs5HCFEiXfLqhW4DNFOtXmWo7qm-c/s400/shoes.jpg" width="400" /></a></div>
<b>Note</b>: For some easy ways to participate in May 12 Awareness Day, please see <a href="http://www.prohealth.com/me-cfs/library/showarticle.cfm?libid=28862">May 12th is International ME/CFS, Lyme, and FM Awareness Day!</a><br />
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<i>This article first appeared on <a href="http://www.huffingtonpost.com/-stephanie-land/patients-with-chronic-ill_b_9818754.html">Huffington Post</a>. Reprinted with permission</i>.<br />
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By Stephanie Land<br />
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Ron Davis, best known for helping to spearhead the Human Genome project, posts a selfie where he’s wearing a cape and a pair of briefs over his regular clothing. Hands on hips in the manner of superheroes everywhere, Davis mugs for the camera, happy to be ridiculous – for a cause.<br />
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Davis is the Board Director at the <a href="https://mailtrack.io/trace/link/b68c251247e924f335ba91da5efcb2457c60a9e5?url=http%3A%2F%2Fwww.openmedicinefoundation.org%2F&signature=a19f66a016e80599">Open Medicine Foundation</a>, a nonprofit set up to raise funds for the research he does with a team (including three Nobel laureates) at the Stanford Genome Technology Center. The Open Medicine Foundation has raised 4 million dollars since 2012 to help combat modern illnesses with elusive etiologies and challengingly complex presentations, such as Lyme, fibromyalgia, myalgic encephalomyelitis. His interest in studying <a href="https://mailtrack.io/trace/link/9ef52ec6f4b3c5be44abf7521681ce77447f316c?url=http%3A%2F%2Fme-pedia.org%2Fwiki%2FMyalgic_encephalomyelitis&signature=4cf71f63e9d9f796">myalgic encephalomyelitis</a> or ME/CFS is to save his son Whitney’s life.<br />
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“ME/CFS symptoms include but are not limited to severe post-exertional fatigue, sleep dysfunction, cognitive impairments, and muscle/joint pain,” explained Stacy Hodges, a 32-year-old who is an advocate and activist for awareness of her condition. “After countless doctors' appointments, many individuals with ME/CFS quickly deplete their life savings but remain unable to work. There is very little hope for a cure, due to the government's lack of commitment to the disease, which results in almost no funding dedicated to medical or scientific research.”<br />
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In a <a href="https://mailtrack.io/trace/link/12d893e468a7f2c17b50d18bf9e286b4466815a7?url=http%3A%2F%2Fwww.openmedicinefoundation.org%2F2015%2F12%2F30%2Fa-plea-from-ron-davis%2F&signature=c2dd92600b48b822">public plea</a> in December of 2015, Davis wrote, “My son Whitney woke me this morning to inform me that he is dying. He did not say he is dying – he cannot speak. He did not write he is dying – he cannot write. He used scrabble tiles to spell out his message.”<br />
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Whitney Dafoe’s <a href="https://mailtrack.io/trace/link/a96e7cafe1576cf73eeec77175ca4e84c1e7dd35?url=https%3A%2F%2Fwww.washingtonpost.com%2Fnational%2Fhealth-science%2Fwith-his-son-terribly-ill-a-top-scientist-takes-on-chronic-fatigue-syndrome%2F2015%2F10%2F05%2Fc5d6189c-4041-11e5-8d45-d815146f81fa_story.html&signature=47b093d6cecfb7b3">story broke into the mainstream media</a> after Ron Davis, his wife Janet Dafoe, and their daughter Ashley Davis held fundraisers to raise money to fund Ron’s research after his grant applications to the National Institute of Health were denied. “This tells me I am running out of time,” Ron went on to say. “I must find out soon what is causing the disease and how to cure it. I know I’m not the only one working on this disease, but there are too few researchers, too few medical specialists, too little research funds and too many patients.”<br />
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“<a href="https://mailtrack.io/trace/link/679a4c6ba9950367b97562ad0675898f72f8aadc?url=http%3A%2F%2Fwww.undiesontheoutside.org%2F&signature=eacdd4f42ed94d89">Undies on the Outside</a>,” a fundraiser set up for the <a href="https://mailtrack.io/trace/link/6cdf6d93a2f8d3ca7ba5070922230c0157dfcdd8?url=https%3A%2F%2Fapp.etapestry.com%2Fonlineforms%2FOMF%2FUOTO.html&signature=ab4c9f6a6e583bd2">Open Medicine Foundation</a>, is only one of many springing up currently as <a href="https://mailtrack.io/trace/link/1989074f10597967cf570590247510902849edcf?url=http%3A%2F%2Fwww.may12th.org%2F&signature=a9b0dcb3ce426cc1">ME Awareness Day on May 12th</a> draws closer.<br />
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An idea for a protest began to form, and Hodges started to articulate what that would look like. “Understandably, the idea of a protest was met with some initial resistance and hesitation because many patients are just way too sick to get out of bed, much less attend a protest,” said Hodges in an email interview. “The co-founders of #MEAction supported the idea of activism and together we launched the first step of many: our protest in Washington, D.C.”<br />
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As the group began planning, and posting about the protest on social media, the idea for a #MillionsMissing campaign started to form. “#MillionsMissing speaks to the invisible nature of our illness,” said Hodges. “Millions of patients are missing from their careers, schools, social lives and families due to the debilitating symptoms of this disease.” There are also millions missing in funds to research the disease, and millions of healthcare workers lacking proper medical training about ME/CFS.<br />
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On May 25th, several groups across the nation will stand (or sit in wheelchairs, lie on stretchers or the ground, depending on their severity of the disease) outside Departments of Human and Health Services to protest a lack of funding to research their disease. So far, there are protests taking place in Washington D.C., Seattle, San Francisco, Atlanta, Dallas, and London, England.<br />
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The combined efforts, fronted by Hodges, have been incredible. Many patients participate in several conference calls a week, sometimes using up their energy reserves to talk, plan, organize, and formulate <a href="https://mailtrack.io/trace/link/0487debc2f36f5fad65aa674581e8274e3de74b3?url=http%3A%2F%2Fmillionsmissing.meaction.net%2Fprotest-demands%2F&signature=f775cbb1f3280468">the protest’s demands</a>.<br />
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Understanding that many patients with ME/CFS won’t be able to attend the protests in person due to being house- or bed-bound, there are <a href="https://mailtrack.io/trace/link/f90f8954e8cb872ce63b16b1b7323e0c39510f83?url=http%3A%2F%2Fwww.meaction.net%2F2016%2F04%2F26%2F10-things-you-can-do-for-millionsmissing-with-one-spoon%2F&signature=2bfa17494b635345">several virtual protest</a> options <a href="https://mailtrack.io/trace/link/2a5abba6cff056e3214cdf492fc818e51da1e4cd?url=http%3A%2F%2Fmillionsmissing.meaction.net%2Fvirtual%2F&signature=4b24c160c6052692">listed on their website</a>. People around the world can mail a pair of shoes to represent one of the millions who are missing from their once-active lives. On the day of the protest, supporters are also encouraged to place a pair of shoes on their front stoop or driveway with a sign explaining who they represent. “At the protest, we will be displaying many pairs of empty shoes sent in from sick and disabled patients around the world, many homebound and bedridden,” added Hodges. “The haunting display of empty shoes will represent the #MillionsMissing who make up our ME/CFS community.”<br />
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Hodges reached out to The Blue Ribbon Foundation, the nonprofit behind the documentary <a href="https://mailtrack.io/trace/link/613bbbc608e74f0781e0d2383075367d6c1cf64f?url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DVsQcmKT3zSo&signature=6c9f13b8ea4de9f2">Forgotten Plague</a>, which features the Davis-Dafoes, showing a rare glimpse into the room where Whitney has lived for over three years.<br />
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The Blue Ribbon Foundation offered a special <a href="https://mailtrack.io/trace/link/e2b72811181bab3b831c841ff2f23e05f0a21814?url=http%3A%2F%2Fwww.forgottenplague.com%2Fproduct%2Fcongressional-pack%2F&signature=1306e3736b409b50">Congressional DVD Pack</a> through the Forgotten Plague website, and joined efforts to attend the protest in D.C.. “Real change is about engaging with the institutions in society that hold the power,” said Ryan Prior, who wrote and co-directed the film. “We need policymakers to watch a film that conveys the human struggle, scandalous politics, and world-changing science of the ME/CFS story. By using the film and the protest to build an increasingly unified front on Capitol Hill we can tell our story in a way we've never done before to the audience we need most.”<br />
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The focal point in each of these campaigns, protests, and fundraisers aligns with Ron Davis’s sentiment: a search for ‘what I can do to start a movement’.<br />
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It’s a movement towards recognition, for people to see how many people are suffering at home in dark rooms, behind closed doors, imprisoned in a body that can no longer function enough to perform daily self-care tasks. “Many patients have no caregivers at all, and they are struggling to get food in their refrigerators or just get to the doctor,” said Hodges. “Many patients are too sick to fight for themselves. Something has to be done, because the status quo is unacceptable. The patients can not live like this. I hope the public recognizes that this is a growing movement.”<br />
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It’s a movement with a groundswell of fundraising, advocacy, and groundbreaking medical research that has the potential to help ME/CFS patients find their feet.<br />
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<b>About the author</b>: Stephanie Land is a writing fellow for the Center for Community Change, and a board member at the Blue Ribbon Foundation. Her work has been featured through <i>The New York Times</i>, <i>The Washington Post</i>, and <i>The Guardian</i>. She lives in Missoula, Mont., with her two daughters. Read more of her story at <a href="https://stepville.com/">stepville.com</a> or follow her @stepville.Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-30887489975572181572016-04-21T12:39:00.001-07:002016-04-23T16:06:32.973-07:00Reductio ad Absurdum: A Webinar with Dr. Avi Nath<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_4_GBwKJiyqAuNMkVbYcGAT5eCFe4yfjm099MIdJI0AxTDUJWUcCB4rahQiHBGjArMMv38enw3qhwdPxVODyJ-rmOsVGgTA-yWfbAWiXwNkGURifpd2joj52wXn3mr75Al5isMOXZ3rc/s1600/logic.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="221" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_4_GBwKJiyqAuNMkVbYcGAT5eCFe4yfjm099MIdJI0AxTDUJWUcCB4rahQiHBGjArMMv38enw3qhwdPxVODyJ-rmOsVGgTA-yWfbAWiXwNkGURifpd2joj52wXn3mr75Al5isMOXZ3rc/s400/logic.jpg" width="400" /></a></div>
On April 21, Solve ME/CFS Initiative hosted a webinar with Dr. Avindra Nath, NINDS intramural clinical director, and the lead investigator of NIH's ME/CFS study. (For those who missed it, the webinar is available on the <a href="https://www.youtube.com/watch?v=g8z-v1F6Ax0" target="_blank">Solve CFS Youtube channel</a>.)<br />
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The first half hour of the talk centered on the NIH study: how it will be structured, how patients will be selected, and how they will be tested. (This information has been presented elsewhere on this blog, so I will not summarize it here.)<br />
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In the second half hour, Dr. Nath responded to questions from the listeners, which Dr. Zaher Nahle, Solve ME/CFS Initiative's Vice President for Research and Scientific Programs, was kind enough to deliver.<br />
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The first question put to Dr. Nath concerned bias among people involved in the NIH study. The answer was "I can't give a litmus test to every researcher."<br />
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There was clearly a misunderstanding about the scope of the question, so Dr. Nahle rephrased the question to ask specifically about bias among the NIH staff. Once again, Dr. Nath responded by reducing the question to absurd proportions, claiming that he didn't have time for "psychological games."<br />
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Neither did Dr. Nath have time to talk to Drs. Fluge and Mella. "I can't talk to everyone who has done a study," is how he answered that question. Of course, Fluge and Mella aren't "everyone." The third phase of the NIH study will involve testing immunomodulatory drugs, one of which may be rituximab. Nobody knows more about the effects of rituximab on ME/CFS than Fluge and Mella, so one would think that a consultation would be prudent.<br />
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There was not much time for further questions, but I have no doubt that Dr. Nath would have sidestepped those as well.<br />
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<b>Reductio ad Absurdum</b><br />
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In rhetoric, the device known as <i>reductio ad absurdum</i> is employed to avoid addressing an opponent's argument. By reducing an argument to absurd proportions, not only is a pall cast over the opponent's point, the discussion effectively comes to a halt.<br />
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Dr. Nath has demonstrated this technique on prior occasions.<br />
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During the NIH telebriefing, Charmian Proskauer, President of the Mass CFIDS/ME/FM Association asked if 40 patients were too few for the study. Dr. Nath replied "If you need to have a thousand patients to find something, it probably isn't worth finding." There are numbers, perfectly reasonable numbers, between 40 and 1000. One hundred, for example, is a reasonable number. But, by exaggerating Ms. Proskauer's argument, Dr. Nath neatly sidestepped the question of whether we really needed another pilot study.<br />
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In like fashion, "I can't talk to everybody" sidesteps the question of whether Dr. Nath will confer with two researchers involved in the only current large-scale study on a drug that has shown promise for ME/CFS patients.<br />
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As for the question of bias, "I can't do a litmus test on everybody," "I can't read minds to see who is biased," and "I don't have time for psychological games," are <i>reductio ad absurdum</i> arguments as well. Nobody has asked Dr. Nath to read anyone's mind. We have simply questioned the appropriateness of three (only three) staff members, two of whom are in key positions.<br />
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The true intent of <i>reductio ad absurdum</i> responses is to belittle the opponent. When this type of rhetorical strategy is employed, the person using it is not only seeking to avoid replying to a point, but to diminish the person making it. (<i>Reductio ad absurdum</i> is only one step removed from <i>ad hominem </i>attacks, which belittle the person directly. Both are considered logical fallacies.)<br />
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The questions posed to Dr. Nath today were phrased respectfully. They addressed concerns that should be taken seriously by anyone conducting a study at public expense. Public scrutiny is to be expected under these circumstances, and yet Dr. Nath appears to believe that we should not be looking at who performs the study, or examining the protocol, or, in fact, asking any questions at all.<br />
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Our tax dollars are paying for this study. It is not only our right to know what the federal government is spending our money on, it is an ethical duty on the part of the government to make full disclosure. Above all, a clinical trial should never be conducted in secrecy, for obvious reasons. And a trial that has even a remote possibility of bias or mismanagement should receive even more scrutiny. That is how good science is conducted.<br />
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Researchers who maintain an attitude of scorn towards the subjects of their studies rarely produce good research. And researchers who do not bother to thoroughly investigate prior as well as current research uniformly produce bad research. While Dr. Walitt has been open about his bias (even while denying that he has one), it is becoming increasingly clear that Dr. Nath's dismissive "I can't be bothered" attitude will be equally problematic in this study.Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-47627469849313557912016-04-21T05:15:00.002-07:002016-04-21T05:15:48.202-07:00Sign the Petition: ME is not MUPS - Dutch Patients Need Your Help!<div class="separator" style="clear: both; text-align: center;">
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On March 29th 2016, the Dutch Health Council (the advisory body to Dutch Parliament) announced the names of the members of a newly formed Committee that has the important task to write an advisory report on the state of the scientific knowledge about ME for Dutch Parliament.<div>
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The idea for the Committee was initiated by ME patients themselves, who, after suffering decades of medical ignorance, requested acknowledgement by the government, as well as a scientific review of ME to support appropriate diagnosis and treatment. <br /><div>
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As is often the case when a government has vested interests in maintaining the status quo, their efforts were co-opted. Half of the Committee members view ME as a psychosomatic illness. Some openly recommend GET and CBT as legitimate treatments for ME. Meanwhile, none of the international experts requested by Dutch ME patients has been included.<br /><br /><div>
The petition “ME is geen SOLK”, which translates as “ME is not MUPS/Medically Unexplained Physical Symptoms” has been launched to redress the inequity of the Committee's composition:<br /><br /><a href="https://petities.nl/petitions/me-is-not-mups-change-dutch-health-council-committee-and-adhere-to-the-advisory-report-assignment?locale=en" target="_blank">https://petities.nl/petitions/me-is-not-mups-change-dutch-health-council-committee-and-adhere-to-the-advisory-report-assignment?locale=en</a><br /></div>
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The purpose of the petition is to support Dutch patients in their request for an accurate scientific review, untainted by biopsychosocial theories. </div>
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Let the Dutch Health Council know that ME (ICD G93.3) is not MUPS, nor it is a somatoform disorder, neurasthenia, functional syndrome or unexplained fatigue.</div>
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Please sign the petition!!</div>
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Following is some background information. </div>
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<i>Reprinted with permission from the Dutch ME patient Group; ME is not MUPS (ME is geen SOLK).</i></div>
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<i>For more information write</i>: <a href="mailto:Meisgeensolk@gmail.com" target="_blank">Meisgeensolk@gmail.com</a>
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<br /><b>Background info</b><br /><br />That the Dutch Health Council was asked to take another look at the state of the scientific knowledge with respect to ME was a direct result of a well known Dutch Citizen’s Initiative “Erken ME”/Recognize ME. </div>
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This group of very ill ME patients was fed up with (the status quo and) the total lack of care and lack of knowledge about this disease with health care professionals in the Netherlands, the total lack of<br />biomedical research in their country, as well as the huge influence of CBT/GET psychologists in the Netherlands (now joined by a growing number of psychologists who stand behind and actively promote MUPS diagnoses, theories and treatments for this patient group). </div>
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ME patients really have no place to go for care, they are only referred to CBT/GET treatments. The Dutch Health Council report in 2005 did not help, it was one of the reasons the CBT/GET paradigm has become so strong in the Netherlands, (as it is in the UK), almost all reasearch funds after the 2005 Health Council report was presented to Parliament went to CBT studies from Nijmegen/Radboud University, who over the years have worked closely with the PACE authors. </div>
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It prompted the Dutch Citizens’s Initiative (Burgerinitiatief) “Erken ME”/”Recogize ME” in 2011. It took more than 2 years. More than 56,000 signatures were collected and presented to Parliament in 2013. They were able (together with 2 ME experts, Prof. DeMeirleir and Dr. Klein, who are now not on the Committee) to convince Parliament members that something needed to change for ME patients in The Netherlands, that the scientific knowledge about this disease justifies a paradigm shift, in care and biomedical research. The result, an official request on April 9th 2015 from Parliament to the Dutch Health Council for a new advisory report on the state of the scientific knowledge with respect to ME.<br /><br />Patient organizations and the Dutch Citizen’s Initiative urged the Dutch Health Council to seek international expertise for its Committee, as true expertise on this disease is lacking in the Netherlands. However, none of the international experts that were suggested to the Dutch Health Council were invited to join the Committee (even though these experts had already said to be willing to participate). </div>
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Now almost half of the Committee members are professionals with a clear SOLK/MUPS and CBT background. One member is a well known Dutch psychologist/“PACE colleague” from Nijmegen/Radboud University, head of the NKCV (Nijmegen Expert Centre for Chronic Fatigue). </div>
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They, for example, provided the protocol for CBT that was (partly) used in the PACE trial, and wrote the well known “Where to PACE from here” commentary that was published together with the original PACE study in 2011 in the Lancet. This commentary included some false/exaggerated “recovery” claims, which was pointed out in a recent letter from more than 40 experts to the Lancet </div>
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The 3 other members that patients are concerned about have a clear MUPS background. CFS, Fibromyalgia and IBS are mentioned as examples of MUPS (SOLK), by them. MUPS is becoming a new “diagnosis”, claimed by psychologists. MUPS “diagnoses” and treatments are linked to the well<br />known underlying biopsychosocial model for MUPS (and CBT), which means patients need CBT and are referred to Mental Health Institutions to get those treatments. A nation wide project is set up (funded by health care insurers) to implement this on a large scale. The SOLK (MUPS) multidisciplinary and Somatoform Disorders guideline in the Netherlands, as well as a SOLK (MUPS) General Practitioners’ Standard (one of the Committee members was involved in writing both), lists CFS as an undifferentiated somatoform disorder (ICD F45). The Dutch “CVS”/CFS Guideline (now considered part of the SOLK guideline) was based on the NICE UK Guideline for CFS. </div>
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Patient organizations have refused to authorize it, yet CBT is promoted as the first choice of treatment for ME patients in the Netherlands. Other professionals with a SOLK (MUPS) background sometimes refer to CFS as a functional syndrome. The NKCV/Expert Centre for Chronic Fatigue (head Hans Knoop, a Committee member) also in several documents describes CFS as an undifferentiated somatoform disorder. The underlying theory of treatment options suggested by these professionals (CBT/GET), the biospychosocial model, is a theory that has never been proven, yet MUPS/SOLK/CBT professionals in the Netherlands claim that it is evidence based and often curative. Besides 4 MUPS/CBT members there are 4 other doctors on the Committee, only two have some experience with ME patients, others don’t.<br /><br />This is why in the Netherlands patients feel so strongly about using the appropriate name and ICD classification for their disease; ME, ICD G93.3. There is a need to get ME out of the CFS umbrella, as suggested by the ICC authors in 2011 and the CFSAC (chronic fatigue syndrome advisory committee) in its recommendations to the HHS in 2015 (recommendations that were based on the IOM and NIH/P2P reports). </div>
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The name CFS is linked to inappropriate classifications for this disease and therefore gives a misrepresentation of what this disease is, i.e. the state of the science says. In their last report in 2005 on “CVS”/CFS the Dutch Health Council Committee also made a clear reference to both ICD F45 (somatoform disorders) and F48 (neurasthenia) as possible classifications for CFS (page 37). But then made the argument that too much focus on the issue of classification was not that important or helpful with respect to relevant treatments.<br /></div>
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On page 37 of the 2005 Dutch Health Council report it states: “The Committee argues, however, that the place of CFS in a classification system says nothing about the nature of the illness and that the CFS case definition is no more than a description of a pattern of symptoms that cannot have any bearing on a discussion about whether it is ‘neurologic or psychiatric’. Furthermore, the Committee does not consider such a discussion to be helpful as far as the treatment of patients is concerned.”. An all too familiar argument still heard today by MUPS/CBT/mental health professionals working with CFS patients: it does not matter if this disease is physical or psychosomatic, they have a treatment that works, so let’s focus on that; …. CBT/GET.<br /><br />The new report of the Dutch Health Council will be highly influencial with respect to health care policy for ME patients in the Netherlands in the next decade (and patients really were hoping for change to get the care they need an more biomedical research so that in time there might be a cure!). For ME patients in the Netherlands it is unacceptable that 10 years after the 2005 Health Council report, with all the available scientific knowledge about this disease and the clear assignment from Parliament to write an advisory report on the current state of the scientific knowledge about ME, for the Dutch Health Council to select a Committee with members that still stand behind the MUPS/CBT (biopsychosocial) theories (and classifications of CFS as MUPS, somatoform disorders etc.) when dealing with this neurological, chronic complex multisystem disease (ME, ICD G93.3).<br /></div>
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Hence, the petition “ME is geen SOLK” (ME is not MUPS) was launched.<br /><br />Patients cannot wait another decade for change! Time to put the biopsychosocial model behind us. We hope you will help Dutch patients by signing and sharing the petition (link).<br /></div>
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<a href="https://petities.nl/petitions/me-is-not-mups-change-dutch-health-council-committee-and-adhere-to-the-advisory-report-assignment?locale=en" target="_blank">https://petities.nl/petitions/me-is-not-mups-change-dutch-health-council-committee-and-adhere-to-the-advisory-report-assignment?locale=en</a></div>
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<br />If you have already signed, thank you, we hope you will continue helping us by sharing the petition link and the concerns of the Dutch patients (a topic relevant to all ME patients worldwide) on your<br />website or via social media.</div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-69676234028704384072016-04-14T08:42:00.000-07:002016-04-14T08:54:41.097-07:00Visiting Whitney Dafoe: a dear friend who suffers from severe ME/CFS<div class="separator" style="clear: both; text-align: center;">
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<i>Reprinted with the kind permission of Stephanie Land.<br /><br />A version of this post first appeared on the author’s website at <a href="https://stepville.com/" target="_blank">www.stepville.com</a></i>.<br />
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By Stephanie Land<br />
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A couple of months ago I discovered my friend Whitney had been bed-bound for over three years. His dad, Dr. Ron Davis, a scientist involved in the Human Genome Project, focused all of his time and effort in researching his son’s disease. I discovered Whitney had been featured in a documentary called "<a href="https://www.youtube.com/watch?v=VsQcmKT3zSo" target="_blank">Forgotten Plague</a>," where it showed him bent over in bed, unmoving, and incredibly thin. The sight brought me to tears.<span style="background-color: white; font-family: "helvetica neue" , "segoe ui" , "helvetica" , "arial" , "lucida grande" , sans-serif; font-size: 13px;"> </span>I wanted to help, and thought, as a freelance writer, I could at least publish articles about Whitney to raise awareness, and decided I needed to see his house in person. My friends didn’t seem to understand.<br />
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I told someone about the time Whitney and I had together, and said it was the perfect summer romance: two kids, in Alaska, playing in fields with muskox and caribou.<br />
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“We had a month. Exactly a month. And he was leaving and we’d never see each other again,” I said. “So we had this month of intense connection without worrying about whether or not it’d turn into a relationship. We could just be with each other, and love each other as much as we wanted without any stress over the future.”<br />
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In going to visit a friend who’s sick, and telling people I’m doing so, most of the reactions are sad moans and frowns. When I said I wouldn’t be able to see him, they’d cock their head to the side a little and furrow their brows in confusion.<br />
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“He can’t tolerate anyone being in his room,” I tried to explain. “He’s too sick. He’ll crash if his brain is forced to process who I am and why I’m there. His body would shut down.”<br />
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“But I thought he only had chronic fatigue syndrome?”<br />
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I barely understood the science of it, or how it worked. The only way I could think of explaining it was that, even though he’d spent most of his time in bed for the last three years, it was more like he’d been resting with his eyes closed.<br />
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“Imagine how you’d feel if you hadn’t had any restorative type of sleep in three years. His entire body is so exhausted, any amount of energy output he’s not prepared for shuts him down to a hibernation-type of state.”<br />
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“From chronic fatigue syndrome?”<br />
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And so it goes. I can’t imagine what it’s like for patients to explain their daily lives to friends and family or doctors.<br />
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It was late at night when I pulled into the driveway of the house where Whitney grew up. Even though his parents, Janet and Ron, had left the door unlocked for me, I still felt like a stranger creeping into the house. It’d been over 13 years since I’d seen Whitney, 10 or 11 since we’d talked on the phone, and over a year since I’d received any kind of message from him. I walked in to find Ron in the kitchen. He smiled so broadly at me, I hugged him.<br />
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Ron and Janet’s nightly routine consists of quietly shuffling in and out of the back room where Whitney lives. The room he never leaves. He has to be prepared for them to enter the room, has to know when to expect them. Once inside, they work quickly to meet his needs then leave him be. On my first night at the house, I watched all of this with a mix of awe and helplessness.<br />
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When I finally went to sleep in the living room, I could still hear Janet moving around in the kitchen.<br />
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I got up the next morning and followed Ron to his office at Stanford, which sits above a laboratory where dozens of scientists, students, and even three Nobel laureates work full-time to research ME/CFS. We walked through the building, and he pointed out work stations, robotic machines, and lab areas. As a writer, I was in a foreign land – math and science were areas I tried to avoid in college.<br />
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But sitting across from Ron at his desk upstairs, I shied a little, knowing I sat with a celebrity. Ron leads the <a href="http://www.openmedicinefoundation.org/donate-to-the-end-mecfs-project/" target="_blank">Open Medicine Foundation</a> as the scientific advisory board director, and is the Director of the Stanford Genome Technology Center. He is recognized as one of the leading scientists studying ME/CFS, and he fights daily to fund his research. “One of the scientists who works for me is retired, and volunteers their time,” he said. “What we need the most is funding.”<br />
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I looked down at Ron’s shoes. Whitney can’t tolerate seeing any kind of lettering at times, and Ron and Janet have to be careful to not wear clothing with any logos. On the front of Ron’s North Face, black sneakers, he’d carefully blacked out the lettering with permanent marker. It was the smallest effort that speaks to how he and Janet work diligently, changing every aspect of their life, tirelessly trying to find a cure for their son, and millions of others who suffer.<br />
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Tibetan prayer flags hang over Whitney’s door, above the porch, and all over the back stoop leading from Whitney’s room. When Janet took me out back to look at the forget-me-nots and African daisies Whitney had planted, she said he might be able to see me from the window. I got nervous and hopeful at the same time. I tried not to look in the direction of his room, but after a while I couldn’t help it. He’d planted my favorite flowers all over the yard, and they, along with the columbine he’d planted for his mom, were some of the only ones in bloom. In the backyard, Janet and I talked in whispers. I caught myself staring at the the back bedroom, at the walls that encased him. At the house that keeps him safe but imprisoned at the same time.<br />
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When I talk to Janet, I always tell her to send Whitney my love however she can. I can’t wait until the day I’m able to do it myself.<br />
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To donate to help Ron’s efforts with the Open Medicine Foundation, and further his much-needed research for a cure, go <a href="http://www.openmedicinefoundation.org/donate-to-the-end-mecfs-project/" target="_blank">HERE</a>.<br />
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<b>About the author</b>: Stephanie Land is a writing fellow for the Center for Community Change, and a board member at the Blue Ribbon Foundation. Her work has been featured through The New York Times, The Washington Post, and The Guardian. She lives in Missoula, Mont., with her two daughters. Read more of her story at <a href="https://stepville.com/" target="_blank">stepville.com</a> or follow her @stepville.</div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-17416832456119112552016-04-11T13:06:00.001-07:002016-04-11T13:06:04.918-07:00My Pen Pals at the NIH<div class="separator" style="clear: both; text-align: center;">
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A few weeks ago I wrote a letter to the NIH <span style="background-color: white;">ME/CFS Trans-NIH Working Group, stressing the fact that Dr. Walitt was not qualified to be Lead Clinical Investigator of the NIH study, or, for that matter, to be involved in the study in any capacity. </span><div>
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The <span style="background-color: white;">Trans-NIH Working Group </span>PR department has finally written me back.</div>
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It was a letter filled with reassurances designed to quell rather than to inform. I have no doubt that the person who wrote it hasn't the faintest idea what the study is about, or who Dr. Walitt is.</div>
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NIH has said that it is open to input from patients. But if their policy is to respond to our concerns with stock replies from their PR staff, what does that say about the value they place on our input? It is a hollow gesture to offer an open door, only to have it lead to an empty room.</div>
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This was my reply to the letter I received from NIH (scroll down to the end of this post to read it):</div>
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April 11, 2016</div>
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<br />Dear Public Liaison staff,<br /><br />Thank you for your response to my letter concerning bias among investigators involved in the NIH study on ME/CFS. You have crafted a reassuring response without actually addressing my point.<br /><br />My point is not that there is <i>potential </i>bias, but that your lead clinical investigator Dr. Brian Walitt is, in fact, biased. His bias has been expressed in a number of publications, as well as in an interview last September. Dr. Walitt believes that patients with fibromyalgia and related illnesses, such as ME/CFS, "catastrophize," that they exaggerate their symptoms, and that their disease has psychogenic origins, specifically in child abuse.<br /><br />Psychogenic theories are a remnant of Freudian psychology, in which various disease states, including MS and gall bladder disease, among others, were attributed to childhood abuse. There is no scientific evidence to support these theories, nor will there ever be. Science demands the rigor of controlled studies, and a limitation of confounding variables. It also demands baseline measurements. The psychogenic claims espoused by Dr. Walitt have not conformed to these basic tenets of science. Instead they have merely echoed an increasingly outmoded style of thinking. His inclusion in this study is not only unfathomable, it is an embarrassment.<br /><br />If this were a study on the biological origins of Alzheimer's disease, ALS, or Parkinson's, would you place someone in a position of authority who believed that these diseases were caused by childhood abuse, or that the patients were "catastrophizing" or exaggerating their symptoms? It would be absurd to include someone with such views, and equally absurd to claim that someone holding those views would not affect the study.</div>
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<br />Dr. Walitt has no place in this study. Neither does Dr. Gill, who holds similar views, nor Dr. Saligan who has jointly published papers with Dr. Walitt espousing psychosomatic theories. If Dr. Collins is serious about studying this disease, as he has so often stated, he should show his commitment by appointing people to positions of authority who are actual experts. <br /><br />Sincerely,<br /><br />Erica Verrillo<div>
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<span id="yui_3_16_0_ym19_1_1460401716392_6256" style="-webkit-padding-start: 0px; font-size: small;"><span id="yui_3_16_0_ym19_1_1460401716392_6255" style="-webkit-padding-start: 0px; font-family: Times New Roman;">Dear Ms. Verrillo:</span></span></div>
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<span id="yui_3_16_0_ym19_1_1460401716392_6260" style="-webkit-padding-start: 0px; font-size: small;"><span id="yui_3_16_0_ym19_1_1460401716392_6259" style="-webkit-padding-start: 0px; font-family: Times New Roman;">Your email to the National Institutes of Health (NIH) ME/CFS Trans-NIH Working Group concerning myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has been forwarded to this Institute for reply.<span style="-webkit-padding-start: 0px;"> </span></span></span></div>
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<span id="yui_3_16_0_ym19_1_1460401716392_6141" style="-webkit-padding-start: 0px; font-size: small;"><span id="yui_3_16_0_ym19_1_1460401716392_6140" style="-webkit-padding-start: 0px; font-family: Times New Roman;"><span id="yui_3_16_0_ym19_1_1460401716392_6246" style="-webkit-padding-start: 0px;">We are pleased that you were able to join us for the NIH telebriefing on ME/CFS last month.<span style="-webkit-padding-start: 0px;"> </span></span><span id="yui_3_16_0_ym19_1_1460401716392_6214" style="-webkit-padding-start: 0px;">You expressed concern about potential bias among the investigators who will be involved with the new ME/CFS study at the NIH Clinical Center in Bethesda, Maryland. </span>Please know that the investigators have a keen interest in finding answers and life-changing treatments for people with ME/CFS. The study protocol is designed to prevent any possible bias from affecting the results, and the <span id="yui_3_16_0_ym19_1_1460401716392_6244" style="-webkit-padding-start: 0px;">large group of associate investigators, combined with the collaboration and oversight of the Executive Committee, should also help to ensure this. We have utmost confidence in the dedicated, multidisciplinary team that will conduct this study, and we sincerely believe that the combined resources and expertise of the NIH will shed light on a previously unsolved medical puzzle. </span></span></span></div>
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<span id="yui_3_16_0_ym19_1_1460401716392_6243" style="-webkit-padding-start: 0px;"><span id="yui_3_16_0_ym19_1_1460401716392_6242" style="-webkit-padding-start: 0px; font-family: Times New Roman; font-size: small;">If you have not already done so, you may wish to visit the Trans-NIH ME/CFS Working Group website at </span></span><a href="http://www.nih.gov/mecfs/about-mecfs" id="yui_3_16_0_ym19_1_1460401716392_6241" rel="nofollow" style="-webkit-padding-start: 0px; background: transparent; color: #196ad4; margin: 0px; outline: none; padding: 0px;" target="_blank"><span id="yui_3_16_0_ym19_1_1460401716392_6240" style="-webkit-padding-start: 0px;"><span id="yui_3_16_0_ym19_1_1460401716392_6239" style="-webkit-padding-start: 0px; color: #0563c1; font-family: Times New Roman; font-size: small;">http://www.nih.gov/mecfs/about-mecfs</span></span></a><span id="yui_3_16_0_ym19_1_1460401716392_6238" style="-webkit-padding-start: 0px;"><span id="yui_3_16_0_ym19_1_1460401716392_6237" style="-webkit-padding-start: 0px; font-size: small;"><span id="yui_3_16_0_ym19_1_1460401716392_6270" style="-webkit-padding-start: 0px; font-family: Times New Roman;">.<span style="-webkit-padding-start: 0px;"> </span>This site will serve to keep people informed about the Working Group’s activities.<span style="-webkit-padding-start: 0px;"> </span>The site includes FAQs about trans-NIH research on ME/CFS, reports from past ME/CFS workshops and meetings, and links to resources on ME/CFS for researchers and patients.</span></span></span></div>
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<span id="yui_3_16_0_ym19_1_1460401716392_6234" style="-webkit-padding-start: 0px; font-size: small;"><span id="yui_3_16_0_ym19_1_1460401716392_6233" style="-webkit-padding-start: 0px; font-family: Times New Roman;"><span id="yui_3_16_0_ym19_1_1460401716392_6263" style="-webkit-padding-start: 0px;">Thank you for your comments.<span style="-webkit-padding-start: 0px;"> </span></span><span id="yui_3_16_0_ym19_1_1460401716392_6232" style="-webkit-padding-start: 0px;">We at the NIH are confident that the new clinical study and other initiatives will support the efforts of the scientific experts who are working on this very challenging disorder and will encourage rapid scientific progress and the development of new ways to diagnose and treat ME/CFS.</span></span></span></div>
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<span style="-webkit-padding-start: 0px;"><span style="-webkit-padding-start: 0px; font-size: small;"><span style="-webkit-padding-start: 0px; font-family: Times New Roman;">We hope this information is helpful.</span></span></span></div>
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<span style="-webkit-padding-start: 0px;"><span style="-webkit-padding-start: 0px; font-size: small;"><span style="-webkit-padding-start: 0px; font-family: Times New Roman;">Office of Communications and Public Liaison,</span></span></span></div>
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<span id="yui_3_16_0_ym19_1_1460401716392_6230" style="-webkit-padding-start: 0px;"><span id="yui_3_16_0_ym19_1_1460401716392_6229" style="-webkit-padding-start: 0px; font-size: small;"><span id="yui_3_16_0_ym19_1_1460401716392_6228" style="-webkit-padding-start: 0px; font-family: Times New Roman;">National Institute of Neurological Disorders and Stroke</span></span></span></div>
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<span style="-webkit-padding-start: 0px;"><span style="-webkit-padding-start: 0px; font-size: small;"><span style="-webkit-padding-start: 0px; font-family: Times New Roman;">on behalf of the Trans-NIH ME/CFS Working Group</span></span></span></div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-51928394820349146632016-04-01T10:29:00.000-07:002016-04-02T06:09:34.918-07:00Mystery of Chronic Fatigue Syndrome Solved!<div class="separator" style="clear: both; text-align: center;">
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By A. Lotta Blarney<br />
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April 1, 2016. Today, the Director of the National Institutes of Health, Dr. Francis Collins, announced that an upcoming NIH study on chronic fatigue syndrome would be cancelled, due to an unexpected breakthrough by its lead clinical investigator Dr. Brian Walitt.<br />
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The breakthrough came after a painstaking review of several thousand research studies in the PubMed database, which revealed the true nature of the disease.<br />
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"It was there all along," said Dr. Collins. "But it took the eye of an expert clinician to find it."<br />
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Chronic fatigue syndrome, according to the NIH, is a complex, multi-system disease that affects nearly every part of the body and produces a plethora of symptoms. The wide array of symptoms, as well as the involvement of the nervous, immune and endocrine systems, have baffled scientists for decades. The question the scientific community could not answer was how one disease could produce so many effects.<br />
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"That's just it," said Dr. Walitt. "When we looked carefully, we found that not only did people with CFS have cytokines, neurochemicals, hormones, and red blood cells, but everyone else did too!"<br />
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This shocking revelation led to another ground-breaking finding.<br />
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"People with CFS have all the major organs that other people have," said Dr. Walitt. "They have arms, legs, torsos, and, in the vast majority of cases, faces, and these commonalities are found across the board. People with CFS have ALL THE THINGS. What's more, they have all these things, and these things that they have are also in their heads, which are attached to their bodies, which is true of everyone else as well. It's a narrative that encompasses all of culture and society."<br />
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"Dr. Walitt's findings will have an enormous impact on how we do science," said Dr. Collins.<br />
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On the heels of its cancellation of the CFS study, the NIH also announced that it would be closing down all of its Institutes in favor of a single Institute : the Institute of Biopsychosocialculturalneuroendocrineimmune Syndromes.<br />
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"Having only one Institute will revolutionize how we do research in the future," said Dr. Collins. "From now on we will devote all our efforts to investigating BS."<br />
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<i>In other Broken News</i>: <a href="http://cfstreatment.blogspot.com/2013/04/cdc-issues-formal-apology-to-cfsme.html" target="_blank">CDC Issues Formal Apology to CFS/ME Sufferers, Changes Name</a><br />
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<a href="http://cfstreatment.blogspot.com/2015/04/iom-opens-marketing-agency-rebrands-all.html" target="_blank">IOM Launches Marketing Agency: Rebrands Chronic Diseases</a>Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-3030781877205021032016-03-28T04:52:00.002-07:002016-03-30T06:10:29.768-07:00NIH Teleconference: Reassurances, Promises, Protestations<div class="separator" style="clear: both; text-align: center;">
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On March 8, NIH held a telebriefing to inform people in the ME/CFS community about their upcoming study, and to answer questions.<br />
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The hour-long conference consisted of short summaries of the NIH study by:<br />
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<b>Dr. Francis Collins</b>, head of NIH<br />
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<b>Dr. Walter Koroshetz</b>, Director of the National Institute of Neurological Disorders and Stroke (NINDS) and chair of the Trans-NIH Working Group</div>
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<b>Dr. Vicky Whittemore</b>, NIH representative to the U.S. Department of Health and Human Services’ Chronic Fatigue Syndrome Advisory Committee (CFSAC)</div>
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<b>Dr. Avindra Nath</b>, Chief of the Section of Infections of the Nervous System at NINDS, and principal investigator of the NIH study</div>
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<b>Dr. Brian Walitt</b>, lead clinical investigator<br />
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Following the summaries, questions were asked by Robert Miller, Cort Johnson, Charmian Proskauer, Jennie Spotila, Lily Chu, Joni Comstock, Wilhemina Jenkins, and Rivka Solomon.</div>
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<i>Scroll down for the full transcript.</i></div>
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<b><span style="color: #990000; font-size: large;">Main Points</span></b><br />
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<li>The in-house NIH study will take over a year to complete. This will be an in-depth study of 40 patients. Over 126 researchers will be involved. Patients with Lyme disease will be used as a comparison group.</li>
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<li>Dr. Collins and Dr. Koroshetz both stressed that they are interested in working with the community, and that they are listening to patients.</li>
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<li>The protocol is a work-in-progress. A lot of bureaucracy is involved.</li>
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<li>Ampligen may be studied in the third phase of the trial.</li>
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<li>Future ME/CFS funding is determined on the basis of grant proposals, and subject to competition from other neurological diseases, such as Alzheimer's.</li>
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<span style="color: #990000; font-size: large;"><b>My Observations</b></span><br />
<span style="color: #990000; font-size: large;"><b><br /></b></span>
<b>Hollow reassurances</b><br />
<b><br /></b>
Dr. Collins stated that the NIH is serious about pursuing ME/CFS research. He asked the community to "stay the course" on more than one occasion, and stressed that the protocol was a "work-in-progress." While Dr. Collins may sincerely believe the NIH is serious about its pursuit of ME/CFS research, what emerged from this teleconference belied the claim. </div>
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The <i>ad hoc</i> nature of this study, among other things, undercuts the claim that the disease is being taken seriously by the NIH. This is an exploratory study, which, while useful in the discovery phase of researching a disease, is untenable after 30 years of research have already been published.<br />
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The popular belief that no good ME/CFS research has been done over the past three decades, and that there have only been pilot studies, or that studies have been poorly designed, and that there have been no consistent results is one that has been promulgated by the NIH itself through the P2P Workshop and repeated <i>ad nauseam</i>. However, a close examination of the PubMed database reveals that there have been many well-designed studies, some large-scale, showing consistent immunological and neurological abnormalities, performed by people who are experts in their field. </div>
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With the amount of knowledge that has been accumulated on immune, endocrine, and neurological dysfunction (not to mention cardiac, muscle, and metabolic abnormalities) this is not the time to go on a fishing expedition. If the NIH was truly serious about establishing the biological causes of the disease, it would build on the research that has been done and appoint experts in the field to positions of authority rather than people with limited knowledge and experience in ME/CFS.</div>
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<b>Study Design Flaws</b></div>
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Very little was said about the actual study design, which is probably because the NIH doesn't have a design in place. However, Dr. Collins stressed that NIH has a "world-class Clinical Center" and Dr. Nath pointed out that invited speakers would give them "cutting-edge knowledge and state of art techniques."</div>
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Ignoring for the moment the fact that inviting researchers to give talks is a far cry from actually possessing that knowledge oneself, and that simply having a "world-class" clinic does not compensate for an ineffectual study design, the idea that study designs can be built by people who are "making it up as they go" is rife with problems.</div>
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For example, the 2-day CPET will not be used in this study. This is an omission that will likely doom this study from the start, because, as Staci Stevens, Chris Snell and their colleagues have discovered, it takes a second exercise challenge to produce the anomalies characteristic of this disease. Given the study's goal of examining the biological consequences of exertion, there is no justification for the NIH's failure to use this "cutting-edge knowledge."</div>
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The second study flaw that has become apparent is in the cross-sectional nature of Phase I of the study. In this phase, Dr. Nath states that <b><i>if </i></b>there’s evidence of inflammation they will surely find it in cytokines. </div>
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Studies dating back to the early 90s, have found evidence of inflammation, and countless others have found immune abnormalities, including the recent cytokine study by Mady Hornig's group. There should not be an "if" because neuroimmune anomalies are a <i>given</i> in this disease.<br />
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Another study design question that arises is, why examine and test patients sequentially? Dr. Nath says it will take a week to test each patient. With 126 researchers and a "world class" clinic, why can't patients be processed simultaneously? It would certainly speed things up.<br />
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And yet another question was raised by Jennie Spotila, who asked why Lyme disease patients were being used as a comparison group. It makes better sense to use a group that has a truly resolved disease process, the flu, for example, rather than one which may or may have not have completely resolved.<br />
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Dr. Nath answered that question by saying that it was a matter of convenience. The NIH already has a lot of information on Lyme disease, which they can use for this study. He also stated that most healthy individuals recover from Lyme disease, which seems to imply that those who don't recover were not healthy to begin with. Nothing could be further from the truth. People who have contracted Lyme disease, and not recovered, were perfectly healthy before getting infected. And as evidence is increasingly showing, people can appear to recover from Lyme disease, and then relapse. (<i>Borrelia burgdorferi</i> is notoriously difficult to eradicate - even in a test tube.)<br />
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Dr. Walitt chimed in to say that because of the characteristic rash associated with Lyme disease, it is easy to pin down "exactly when the infection started." However, <a href="http://www.bayarealyme.org/blog/lyme-disease-bullseye-rash/" target="_blank">up to half of the people</a> who contract Lyme disease either don't get a rash, or don't notice it. (This is especially true when the tick bite occurs on the head, or when the person has dark skin.)<br />
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Not only is Lyme disease a poor comparison group on the basis of the many unanswered questions surrounding it, the clinical investigators appear to have as little understanding of Lyme as they do of ME/CFS.<br />
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<b>Bias and Implausible Deniability</b><br />
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One of the questions raised in the Q&A session by Lily Chu and Wilhemina Jenkins was that of bias.<br />
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Both Dr. Gill and Dr. Walitt have expressed the viewpoint that ME/CFS is a psychosomatic entity, by which they mean it is psychogenic and/or is perpetuated by psychological states ("illness beliefs"). Dr. Gill has advocated both graded exercise (GET) and cognitive behavioral therapy (CBT) as effective treatments for the disease, and Dr. Walitt has published several papers proposing a psychosocial model (aka psychocultural, biopsychocultural, and other variations) for fibromyalgia and ME/CFS.<br />
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In response to Wilhemina Jenkins' question about bias, Dr. Walitt stated flatly, "I don't have a bias." He was obviously, and quite deliberately, lying. There is no "wiggle room" for interpreting Dr. Walitt's views, which he has not only published in more than one paper but stated directly in an interview.<br />
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Dr. Walitt's reply was that "if Chronic Fatigue Syndrome, Myalgic Encephalomellitus [sic - he was not able to pronounce the word "encephalomyelitis"] is all in your head, it’s only because your head is part of your body." This obscure statement does not contradict his opinion that psychological states produce the physical symptoms of fibromyalgia and ME/CFS. The idea that diseases can be produced and perpetuated by psychological or emotional states is part of Freudian mythology, and it has been promoted by psychiatrists as an etiological explanation for ME/CFS since the 1970s.<br />
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The notion that diseases spring up as they become socially "fashionable" is a related idea that was popular in the early 90s, and it is one that has as little evidence to support it as somatization disorder. Yet, Dr. Walitt has unequivocally stated that fibromyalgia is a <a href="http://www.ncbi.nlm.nih.gov/pubmed/23820862" target="_blank">"psychocultural" construct</a>" - something invented by politicians, rheumatologists, and patients who are exaggerating their symptoms.<br />
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In like fashion, Dr. Walitt states that an infectious trigger for chronic fatigue syndrome is something <span style="background-color: white; font-family: "times new roman" , "stixgeneral" , serif; font-size: 15.9991px; line-height: 21.9988px;"><span style="background-color: white; font-size: 15.9991px; line-height: 21.9988px;">"</span></span><span style="background-color: white; font-family: "times new roman" , "stixgeneral" , serif; font-size: 15.9991px; line-height: 21.9988px;"><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750385/" target="_blank">whose validity is not answered by the scientific literature to date</a>." </span>This claim is not only unsupported, it reflects a preconceived notion of the illness. Bias is so clearly evident in Dr. Walitt's writings that the only basis for his denial can be that Dr. Walitt believes his psychosomatic theories of ME/CFS are indeed undisputed. He may even believe that what he is doing is scientific.<br />
<span style="background-color: white; font-family: "times new roman" , "stixgeneral" , serif; font-size: 15.9991px; line-height: 21.9988px;"><br /></span>However, science demands not only proof, but the possibility of refutation. Psychogenic theories of disease cannot be proven, nor can they be disproven, because they belong to the realm of superstition, not scientific inquiry. Furthermore, if Dr. Walitt would like to claim that there is not enough scientific evidence for an infectious trigger, he certainly can't turn around and claim that uncontrolled, interview-based, post-hoc, retrospective studies totally <i>lacking</i> in scientific rigor can determine a psychological cause.<br />
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It would be wildly optimistic to believe that this type of bias - not to mention the stunning ignorance - in the NIH's chief clinical investigator won't affect the course of this study.<br />
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<b>Future funding</b><br />
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In reference to funding further [extramural] research Dr. Koroshetz replied that "NIH has processes that ensure that research comes in and the most highly meritorious research is funded and that all groups have a fair hearing when they come in." He stated that this is a "tried-and-true" process.<br />
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Interestingly, this "tried and true" process has recently been found wanting. A <a href="https://www.sciencedaily.com/releases/2016/02/160216090128.htm" target="_blank">February 2016 study</a> by Johns Hopkins University Bloomberg School of Public Health found that peer review for NIH grants was no better than random selection. One of the study's authors, Arturo Casadevall, stated that the current system is "worse than awarding grants through a lottery."<br />
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Among other problems with grant selection, personal preference enters prominently into funding decisions. "When people's opinions count a lot, we may be doing worse than choosing at random," Casadevall says. "A negative word at the table can often swing the debate. And this is how we allocate research funding in this country." That explains a lot.<br />
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It explains why research proposals for ME/CFS have been consistently turned down, even when they come from researchers who are renowned in their fields. One word from someone who thinks ME/CFS is "all in their heads" is all it takes to throw a grant into the trash. They don't even have to read it.<br />
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Give Dr. Koroshetz' faith in the system, how likely is it that he will take steps to change it?<br />
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<b>Bureaucracy in Inaction</b><br />
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Dr. Koroshetz remarked that when it comes to research, a lot of "bureaucracy" is involved. Those may have been the most meaningful words spoken at this teleconference. Bureaucracy is what has driven the choice of "clinical experts" to oversee this study - not one of whom has clinical expertise in this area.<br />
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Bureaucracy has driven the choice to conduct an exploratory intramural study, rather than fund the focused, dedicated and knowledgeable experts who have been working in this field for years - some for decades.<br />
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Bureaucracy has driven the decision to exclude severely ill patients, who have been included successfully in other studies, and to omit one of the most clinically significant tests of the last decade.<br />
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And regardless of the reassuring words, promises, and pleas for forbearance, it is a blind, self-limiting, self-perpetuating bureaucracy that has forced the likes of Dr. Walitt upon us.<br />
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<i>The email address to submit comments to NIH is</i>: braininfo@ninds.nih.gov<br />
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<i>You can also address questions about the study to</i>: NIHME-CFSWorkingG@ninds.nih.gov</div>
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<i>You can listen to an audiofile of the call as well as read the transcript</i> <a href="http://www.nih.gov/nih-me/cfs-advocacy-call" target="_blank">HERE</a>. </div>
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<b>Transcript </b></div>
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March 08, 2016<br />
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9:00 am CT<br />
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<b>Coordinator</b>: Welcome and thank you for standing by. At this time, all participants will be on a listen-only mode until the question and answer session of today’s conference.<br />
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At that time to ask a question over the phone lines, please press star 1 and record your name at the prompt. This call is being recorded. If you have any objections, please disconnect at this time.<br />
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I would now like to turn the call over to your host, Marian Emr. You may begin.<br />
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<b>Marian Emr</b>: Good morning. This is Marian Emr. On behalf of the NIH, I would like to welcome you to this morning’s teleconference and to thank you for your great interest in participating in this discussion with us today.<br />
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Here at the table this morning, we have Dr. Francis Collins, Dr. Walter Koroshetz who will introduce Dr. Vicky Whittemore, Dr. Avindra Nath and Dr. Brian Walitt.<br />
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Each will make very brief opening remarks and then we’ll open the phone call for your questions. Please be patient with us through this process. We will try to get to as many questions as we can in the time we have available to us this morning. Now Dr. Collins.<br />
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<b>Dr. Francis Collins</b>: Thanks and good morning everyone. I wanted personally to join this call to thank you for joining us for what I hope is an ongoing conversation about ME/CFS and how we can move the needle forward together on characterizing the cause of this perplexing disorder to help with better diagnosis and treatment.<br />
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I want to assure you that from the perspective of the NIH Director, that this institution is very committed to this area of research. Speaking for many of us, we want to move the research agenda forward here both in terms of intramural activities -- which you’ll be hearing about -- and extramural research programs as well.<br />
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I’m happy to tell you that with regard to the intramural effort, we have received IRB -- that’s Institutional Review Board -- approval and expect to be able to launch this study at the NIH Clinical Center and then begin to enroll individuals this summer.<br />
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I have great confidence in Avi Nath, who’s the principal investigator, who’s going to speak to you here shortly, who will lead this important study. And he can tell you more about it.<br />
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A Web site describing the intramural protocol actually went up this morning. If you haven’t seen it yet, this will give you a lot of the details about the design of this study and how it’s going to be conducted.<br />
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And I think this is a remarkable opportunity to try to bring the whole power of this really remarkably, interdisciplinary research hospital to bear on this set of serious questions about what are the causes of ME/CFS.<br />
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There’s a lot of heterogeneity of course in this condition. The choice here was to focus on individuals who had previously good health and then a clear-cut onset in the context of a flu-like illness, in order to limit the heterogeneity and provide us with a better opportunity for getting answers.<br />
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And we believe that this study in the world-class Clinical Center of NIH has the opportunity to provide some new insights that could be transformative for all of those who suffer from this condition.<br />
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So in addition, on the extramural side, a vigorous, reinvigorated Trans-NIH Working Group is working to define the strategic areas of research that would form the basis for a request for applications to the extramural community, both in the short-term and in the longer term.<br />
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And Dr. Koroshetz can tell you more about where we are about that particular set of discussions. We’re quite serious about looking for opportunities to expand our research in this area and to recruit new investigators into the field, bringing new eyes and new brains into the issue of trying to understand the puzzling aspects of this, that previously have eluded us.<br />
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So please take our commitment with great seriousness. Please also stay the course with us as we seek to identify the most compelling research questions and how we could address those.<br />
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I understand many of you have waited a long time, perhaps, to see this kind of attention. I hope you understand how much we are now looking at this in a very serious way and seeking to come up with some of those answers.<br />
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So if we can work together on that and not work apart, I think we have a much better chance of making real progress. We are your partners. We want to hear from you.<br />
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That’s why we’re having this call today. And we’re listening carefully to the comments and the suggestions you might have about how best to move this effort forward.<br />
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So that’s mostly what I wanted to say by way of introducing the call. I now want to turn this over to Dr. Walter Koroshetz who, as you know, is the director of the National Institute of Neurological Disorders and Stroke.<br />
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Walter is a neurologist -- a very experienced one -- and he has seen firsthand how devastating ME/CFS can be for patients. And he volunteered to chair this Trans-NIH Working Group and is working closely with other institute and center directors to promote research on ME/CFS.<br />
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And I want to say thank you to Walter for stepping into this space, and already with considerable vision, figuring out ways that we can make the kind of scientific contributions that this field very much needs. Walter, the floor is yours.<br />
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<b>Dr. Walter Koroshetz</b>: Thank you always Francis and again, I’d like to thank everyone for getting on. And I’d like to thank everyone for the expressions of interest and even the concerns that people have sent to us.<br />
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We are very interested in working together with the community to achieve our long-term common goal. And I think that common goal is shared unanimously, which is to find better treatments for people who are suffering with ME/CFS.<br />
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And I can just - like to start off by talking about the big picture - the intermural research protocol, I think, is one step but only one step in the trajectory that we need to get on to get answers that are going to be very helpful for patients.<br />
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And so this is, I think, a long-term quest. This is a difficult problem. I think if it was not difficult it would have been solved long ago. So I think we need to kind of get out there and bring in the best and the brightest from many different areas of science.<br />
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I don’t think we know where the solution is going to come from. So I think we need to cast a wide net, get involved a number of very experienced researchers and clinicians and work carefully with the doctors who are taking care of the patients.<br />
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As Francis said, I think the important thing is to stay the course and to look always to the long-term goal. At NIH, we have some bureaucracy which is not easy to understand.<br />
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But I would like to simplify it if I could that there is basically an extramural program, and the extramural program - you know, funds that go from the NIH out to universities, companies, other institutions to do research.<br />
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And there’s the intramural program where research is done at the Clinical Center in the Bethesda area. The Clinical Center is the world’s largest research hospital and really our only research hospital.<br />
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It has tremendous resources, but 90% of the funds from NIH go out to the extramural community. So in the long run, what we need to do is to engage both the extramural and the intramural community.<br />
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And you’ll hear about the intramural protocol which is starting up, but you also heard mentioned from Dr. Collins that we have a Trans-NIH Working Group. As I mentioned, we don’t know where the solution for this ME/CFS problem is going to come from.<br />
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So it’s very important to have the scientific input and the funding resources of multiple institutes at NIH to bring them to bear on this problem. The Trans-NIH Working Group has representatives from all the institutes and is working to develop plans that will move funds to very worthwhile, highly meritorious research proposals in the extramural community.<br />
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And we have the intramural program protocol which is going to be run by Dr. Nath. With that I’d like Vicky Whittemore to briefly describe the Trans-NIH Working Group and what it is about and thinking of doing in the short-term and the long-term. Vicky?<br />
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<b>Dr. Vicky Whittemore</b>: Good morning. This is Vicky Whittemore and I’m a program director at the National Institute of Neurological Disorders and Stroke. And I also would like to thank all of you for being on the call this morning.<br />
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I’ve been working with Dr. Koroshetz to coordinate the Trans-NIH Working Group and I have to say it’s really been a pleasure working with representatives from the staff of the 23 institutes and centers who make up the Working Group.<br />
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Everyone’s really dedicated and passionate about what we’re doing and what we’re working on. We are in the process of putting together as Walter said both a short-term plan, where we can try to activate some research on the shorter-term as well as initiative that would put in place better infrastructure as well as research funding for longer-term research projects.<br />
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And some of things we’ve been talking about -- clearly as the community has communicated to us as well -- the priorities of developing and identifying biomarkers for the disease, really understanding the underlying causes and mechanisms that lead to ME/CFS as well as getting a handle on and understanding what is causing what patients refer to as brain fog or the cognitive symptoms that many individuals with ME/CFS experience.<br />
<br />
So our timeline is that we’re working very hard to put this plan in place and to present our initiative to the appropriate council for approval in the May timeframe and we will - to move forward with the initiative soon after that.<br />
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So we will be looking for input and feedback from the community. And I think several ways that we’re thinking about doing that is to put out specific requests to the community for feedback on ideas we have and things we’re thinking about, to have additional follow-up conference calls after this one in due time.<br />
<br />
As well as to reach out to the research and clinical community to get feedback from them as well in terms of what we’re thinking and planning. So with that, I’ll turn it back over to Dr. Koroshetz.<br />
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<b>Dr. Walter Koroshetz</b>: <span style="color: red;">So I just want to clarify one thing because I’m sure people are wondering out there why can’t we actually say what we’re thinking. And so it is important to understand that NIH has processes that ensure that research comes in and the most highly meritorious research is funded and that all groups have a fair hearing when they come in.</span><br />
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So what we can’t do is we can’t put information out before it’s ready to be made public to everyone. So that’s why we have to do a lot of work behind-the-scenes before we can make things public.<br />
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So it’s a kind of something that’s idiosyncratic, but it has its real purpose in presenting a fair and open process here at NIH. And that now I’d like to say also that as I mentioned before, I think it’s going to take an army of really good researchers to solve this problem.<br />
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I think that army has to work together. It can’t be individual groups working in isolation. So what we’d like to do is to form a consortium really of investigators who are working hand in step.<br />
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Not all doing the same thing, but a lot of innovation. And the first horse out of the gate is the intramural program. So I would like Dr. Nath, if he could, to try and briefly describe what the intramural protocol is all about. And I would add that Dr. Nath is calling in from Liberia where’s he doing fieldwork in Ebola.<br />
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And so we’re very gratified that Avi can get on the call and we hope that his line stays stable from Africa. Avi, would you like to describe the intramural protocol?<br />
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<b>Dr. Avindra Nath</b>: Oh thank you very much, Walter. This line should be fine because I’m using one at the U.S. Embassy.<br />
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<b>Dr. Walter Koroshetz</b>: Okay. Good.<br />
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<b>Dr. Avindra Nath</b>: So well thank you very much. So, you know, I’m delighted to be the principal investigator of the intramural study. And when Dr. Collins and Dr. Koroshetz asked me to consider this responsibility, I was actually very thrilled to be able to look at the syndrome and see if there is an immune or neuroimmune component here that may be driving the disease.<br />
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That is an area of my expertise. I have firsthand seen a lot of patients with the disease and know exactly how devastating it can be. And so, when I looked at the literature, it was very clear to me that there are very good reasons to believe that this is likely immune-mediated.<br />
<br />
And so I designed a protocol that would address those kinds of issues. So the proposal I put together has three phases to it. The first phase is a cross-sectional study and that’s the protocol that’s on the Web and all the information that many of the groups have received.<br />
<br />
However, and in in the plans is our second phase study. The second phase study would be a longitudinal study which will follow patients over a period of time with repeated testing but only with a small subset.<br />
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The first phase study has a lot of various kinds of investigations we will do. And then we’ll identify the ones from there that look most promising. And then in the second phase study, a much larger population, different types of population and then be able to study them over a longer period of time.<br />
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And then the third phase would be an intervention study. So based on the information that we gathered from the first and second phases that will guide us as to what kind of immune-modulatory therapy would have the best opportunity of making a difference in this patient population.<br />
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So that in summary is what we were thinking about as our goal towards developing a research protocol for a chronic fatigue syndrome.<br />
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<b>Dr. Walter Koroshetz</b>: Thanks very much Avi. Can you still hear us all right? Okay. So now I think I’d like to turn to Brian. Brian Walitt is a medical officer at the National Institute of Nursing Research.<br />
<br />
He’s had considerable clinical and research experience in fibromyalgia and ME/CFS research. And he’ll serve as the lead associate investigator to help Dr. Nath coordinate the activity of a large number of investigators who will be involved in the study at the Clinical Center.<br />
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So Brian, do you want to tell us a little bit about what brought you to this really interesting protocol?<br />
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<b>Dr. Brian Walitt</b>: Yes, sure. Thank you Walter. Hi, I’m Brian Walitt. I am the lead associate investigator on the intramural protocol here at the NIH. My experience with all of this starts in my career in rheumatology where I had a lot of experience with hospital immune disorders and developed a specialization in fibromyalgia and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.<br />
<br />
My interest in the disorders grew over time and led me to open a research clinic at Georgetown University where I saw patients on a regular basis. My patients taught me just how real these disorders are.<br />
<br />
They are not just in one’s head. They do not reflect some unconscious choice and it is not possible to simply push through the symptoms. I tried my best to help my patients and learned just how limited the options really are and why there is an urgent need for a restorative treatment.<br />
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One that would give patients their lives back. I promised my patients I would do my best to find better answers for them. This passion is what led me to come work at the NIH.<br />
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Since I’ve been here at the NIH, I’ve been learning the ways that research is done here. I’ve learned a great deal about science from the world-class scientists that I get to rub elbows with.<br />
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I’m very lucky in that regard. I am very excited to help Avi Nath facilitate the protocol. I believe it’s going to provide some important answers to the big questions of ME/CFS: the role of infection, the role of immunity and the role of neurology and the generation and perpetuation of symptoms.<br />
<br />
We’re also going to try to understand exactly what the biology of post-exertional malaise is. I believe these things will move the needle forward as Dr. Collins said. And I’m very excited to be part of this.<br />
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<b>Dr. Walter Koroshetz</b>: Thanks very much Brian. So I’d also just emphasize that the protocol at NIH has 26 associate investigators in addition to Brian and Avi, and they bring this really incredible expertise to the table in the study of the patients with ME/CFS in this protocol.<br />
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And this ranges from very high-level neuroimaging to high-level ability to look at cytokines, autoantibodies and we have people like Leo Saligan in the Nursing Institute as well who has been looking at chronic fatigue in patients with cancer and rheumatologic disorders.<br />
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So we have a really quite an amazing group and it’s different than what you might see in a hospital on the outside because everyone here is full-time devoted to research.<br />
<br />
And so the community of researchers is quite extraordinary. And also the tools that we have in the Clinical Center are quite extraordinary. Very difficult to bring a patient in who’s very ill for research at a hospital any longer.<br />
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But here we have an in-patient unit where we can study patients over multiple days, even weeks. So we’re hoping that the resources of the Clinical Center will allow us to do some very unique things.<br />
<br />
But I would also emphasize once again that this is a stepping stone. This is only one piece of the puzzle. I think it’s a very important piece but what our intention is, is to coordinate it with many of the other pieces that we’re going to start initiating across the country.<br />
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And with that, I’d like to open the phone to questions now and we’ll do our best to answer them. And once again, if we are not able to answer all of the questions, they can be directed to a Web site: <b>braininfo@ninds.nih.gov</b>. So thank you very much and let’s open the lines. First question?<br />
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<b>Coordinator</b>: Thank you. We will now open the question and answer session. If you would like to ask a question over the phone lines, please press star 1 on your phone and record your name at the prompt.<br />
<br />
To withdraw your question, press star 2. One moment please for incoming questions. And our first question comes from Robert Miller. Your line is open.<br />
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<b>Robert Miller</b>: Hi, good morning everyone. This is Robert Miller. I’m a long-time patient and advocate. And first I’d like to thank Dr. Collins, Dr. Koroshetz and team for taking this key first step in doing the Clinical Center study for ME/CFS.<br />
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I think it’s a long-time coming for this patient population. But I’d like to start off and address actually possible treatments and in particular the treatment Ampligen.<br />
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And I’d like to ask what homework has been done thus far regarding Ampligen and if there’s been any talk with the FDA, as this is the only treatment ever to be into Phase III trials for ME/CFS.<br />
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And that opening for this drug potentially could lead to this drug being our - or this patient population’s, AVT. You know, opening the door to pharma for much more research.<br />
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And most importantly it would give relief to many suffering patients. Thank you.<br />
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<b>Dr. Walter Koroshetz</b>: So thank you Mr. Miller. And, you know, indeed as I mentioned the goal that we’re all marching towards is to try to get a treatment. And clearly, to start off I think we are going to challenge our investigators to survey the area of therapeutics that have been tried in ME/CFS.<br />
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Others that might have been tried in other illnesses that might come into ME/CFS because those are more of the short-term wins should they be, effective.<br />
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Developing new therapies is basically a ten to longer process. So that is very important. And so we certainly at the NIH have open-door policy for people to come in and propose research.<br />
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And we have certainly met with many investigators and even the Hemispherx Company people and they presented the data that they have from their previous studies. And so that certainly is something that we are taking into serious consideration.<br />
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As I mentioned earlier, there is a process at NIH for the funds to go out. So the process is, again, a peer review process where investigators submit proposals, they get looked at by the leadership and then they go out to a peer review system and they kind of poke holes to make sure that the best proposals get the funding from the American taxpayers.<br />
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So that’s the system that would have to be engaged. It’s very different from an industry system where the industry makes the decision to put the funds down and they take all the risks.<br />
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Here we’re working with taxpayers’ dollars and so the process is very important to uphold. But certainly we are looking at that and we expect that we’ll be having discussions on the clinical trials as they come forward. So thanks very much for that question.<br />
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<b>Robert Miller</b>: Thank you.<br />
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<b>Coordinator</b>: Our next question comes from Donna Pearson. Your line is open.<br />
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<b>Donna Pearson</b>: Thanks very much. So there is substantial confusion between the diseases that you’re studying and other conditions involved in unspecified chronic fatigue. And that confusion impacts research, medical education, diagnosis, treatment and care at every level.<br />
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And I know that the name is not an issue that many people want to talk about in research. However, a name is the single most obvious way to distinguish a disease from another disease.<br />
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I mean I wouldn’t clearly agree that a name change is appropriate. I’d suggest the establishment of a new ICD code. So my question is, does the current study and the tests that you will be doing have the potential to determine if encephalomyelitis is in fact an appropriate name for the disease?<br />
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<b>Dr. Walter Koroshetz</b>: I’m not sure if Avi is still on the line.<br />
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<b>Dr. Avindra Nath</b>: Sorry, I’m here. I’m here. Yes.<br />
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<b>Dr. Walter Koroshetz</b>: Okay.<br />
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<b>Dr. Avindra Nath</b>: So, we are not looking at every single aspect of the disease. We are looking at a select population. And in that population, we can certainly tell you if there’s evidence of inflammation.<br />
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<b><span style="color: #cc0000;">And if there’s evidence of inflammation then I think it’s fair to say that if present, an inflammatory process in the brain.</span></b> <b><span style="color: #cc0000;">Whether we use the word encephalomyelitis, the problem is that you have to demonstrate there’s an infiltration of cells.</span></b><br />
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Just activation of immune system in the brain alone is not sufficient to cause encephalomyelitis. You can get activation of the immune system in patients with Alzheimer’s disease or Parkinson’s disease. We don’t particularly call that encephalomyelitis.<br />
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But I think we will get closer to that answer because we will be able to look at a panel of cytokines and we may have some suggestion as to what kinds of cells are producing the cytokines.<br />
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And so, yes we will get closer to that definition. Whether we are able to establish it beyond an element of doubt or not, it won’t be from this study. We are planning some animal studies and I think that it’ll be a better chance for being able to answer that.<br />
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So the animal studies will take lymphocytes from the patients, inject them into the animals and try to reproduce the disease. If we can, then we can look at the brains of the animals and actually tell if their cells are infiltrating or not, if we produced the phenotype or not.<br />
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I think those kinds of studies have a much better chance of being able to answer the question that you addressed.<br />
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<b>Dr. Walter Koroshetz</b>: Let me just add a couple of points because I think they’re important to understand. And I’d say that the protocol at NIH is interested in trying to get at the biology, the biological basis of the illness.<br />
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Now eventually that might, the biologic basis of the illness in most of the illnesses is eventually what moves the definitions and allows break-up in the heterogeneity of a disorder.<br />
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It’s a particular biological entity. That process is a long process. And so, I would urge people to basically stay the course there. Clearly this protocol which is looking currently at 40 patients - what they find will then need to go into another stage to be validated in other groups of patients to make sure that it’s a real finding that can be generalized.<br />
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So generalizability is the next step that would come when a discovery is made. One reason we think it’s real important to organize ME/CFS researchers across the country is because many studies have discoveries but they’re never really validated to know if they’re generalizable.<br />
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And so, I think we have a lot clues in the literature but one thing we need to do is to make sure that they can be generalized across the population. And the expectation is, I think, that there are multiple, different types of ME/CFS.<br />
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And it may not, something we find here may not generalize. This protocol is for persons who develop the condition after a flu-like illness. There are other ME/CFS patients who develop the condition after other types of exposures.<br />
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Environmental exposures, allergic exposures, traumatic exposures. So we can’t solve the whole problem with this one protocol. This is, again, a piece of the puzzle. I urge people to think of it in that way. Okay. All right. Can we go to the next question?<br />
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<b>Coordinator</b>: Our next question comes from Cort Johnson. Your line is open.<br />
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<b>Cort Johnson</b>: Thanks. As I’m sure you’re aware that Ron Davis is taking on a similar exploratory study. And so what I was wondering was if it’s possible for Davis to follow-up on findings that you get and vice versa?<br />
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Can your team follow-up on findings that he gets? Is it possible to give him some funding to be able to do that? And my second question involves the exercise study.<br />
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Staci Stevens at Workwell has worked for years to develop standardized exercise protocols that work for ME/CFS patients. That exercise portion of the study is probably a critical part of the study. Is the team planning to contact her and work with her to be able to use a similar protocol in their study?<br />
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<b>Dr. Walter Koroshetz</b>: Okay. Brian, could you address the exercise protocol and then Avi, maybe if you could address the data sharing next?<br />
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<b>Dr. Brian Walitt</b>: So the exercise protocol for the study that we’re doing in the intramural program is designed to induce post-exertional malaise. Right? It’s a maximal effort exercise intervention.<br />
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It’s designed to provoke symptoms as opposed to being a treatment. The CDC, Beth Unger, has a lot of experience in doing this kind of work. And we’re going to be talking to them about designing proper ramps and so forth.<br />
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However, we are open to suggestions from all people with experience and we would be happy to reach out to others that may have useful things to add as we design the intervention.<br />
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<b>Cort Johnson</b>: Thanks.<br />
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<b>Dr. Avindra Nath</b>: This is Avi. Let me just add to that. So,I did talk to Dr. Davis and we are absolutely delighted to collaborate with him. The kind of study he’s doing is not exactly the same that we are proposing to do.<br />
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So I discussed that with him in great detail. We actually exchanged a number of...<br />
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<b>Dr. Walter Koroshetz</b>: Oops. I think we dropped off Avi. But I think his point is that that yes he has been in contact with Dr. Davis and actually a number of other investigators around the country who are collecting samples and they will be sharing data.<br />
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Now I think also as we mentioned, what we’re hoping to do is to set up a series of investigators around the country who can work in concert with each other and share data.<br />
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As particularly with regard to looking at the second issue I mentioned before, which is generalizability. If you find something in one group and you check another group that you think is similar, do you see those same findings or not?<br />
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Unfortunately the history of these kind of biomarker studies is such that it’s a lot of things fall out and don’t replicate. So you really need to do this coordinated approach to make sure that what you’re putting your money on is a real thing. A real finding.<br />
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Okay. Can we go to the next question?<br />
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<b>Coordinator</b>: Our next question comes from Charmian Proskauer. Your line is open.<br />
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<b>Charmian Proskauer</b>: Hi. Thank you very much for this opportunity to have a discussion. I think this is great. You may have already answered this question in part through things that you’ve already said.<br />
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But I’m going to ask it anyway. Why only 40 ME/CFS patients? I realize that this is a very deep study but with 40 patients does that have the danger of falling into the category of just another pilot study with numbers too small to be really meaningful? That’s my question.<br />
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<b>Dr. Avindra Nath</b>: So let me address that. This is Avi.<br />
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<b>Dr. Walter Koroshetz</b>: ...question...<br />
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<b>Dr. Avindra Nath</b>: So there are two aspects to it. Number one is we’re going to be screening patients. It’s going to take us awhile. And then when we admit the patients, they're going to be in for a week. So it’ll take us one patient per week.<br />
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So even if, you know, give or take 40 patients, it’s going to take a minimum of one year just to study 40 patients. Plus you’ve got the controls. So it’s going to take you a while to actually get through this population.<br />
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So if your entries are more and more, it’s going to take you longer to get to the answer. The other thing is that we’re selecting a very precise population. Within 40, there’s at least - calculated a lot sample sizes based on the information that we have.<br />
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<b><span style="color: #cc0000;">If you don’t find a neuroimmune, you know, abnormality in 40, then it’s unlikely to be a major driver of the disease.</span></b> And I’m pretty certain that this is a decent sample size for us to be able to find the kinds of immune abnormalities that we’re looking for.<br />
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So I think the sample size is pretty decent and it gives us an opportunity. And after that like I said, we’ll do a longitudinal study. So then you can enroll as many patients as you want from all over the country.<br />
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And other people can participate in the study and take those findings and look at multiple groups. So you have second phase of the study that allows you to do a more expansive study.<br />
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But you don’t want to do a huge expansive study the first time around. If it takes 1000 patients to find something, it probably isn’t worth chasing a result.<br />
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<b>Dr. Walter Koroshetz</b>: I think I’d also add that at NIH there’s a culture which is actually a try-and learn-as-much-as-you-can from every single patient. So there is, for instance, an undiagnosed disease clinic here where people come with diseases that could not be diagnosed on the outside. And they found causes for many of these patients.<br />
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They were all different though. So I think, you know, it’s also possible that with the kind of in-depth analysis that there may be very robust findings in even one or a small group of patients that will be very important. So it’s a little bit different - it’s definitely not an epidemiological study. The NIH is much more - it’s advantage is in deep study of small numbers.<br />
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But I think as the question you posed, the issue that to actually get the answer for all the patients who have ME/CFS, this is just one step and we have to see what we discover and how generalizable it is to the population.<br />
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And that’s going to require multiple steps and a larger group of investigators. Can we go to the next question?<br />
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<b>Coordinator</b>: Our next question comes from Joni Comstock. Your line is open.<br />
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<b>Joni Comstock</b>: Hi. I represent MEadvocacy, a grassroots, non-profit organization advocating for patients suffering from ME.<br />
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<b>Dr. Walter Koroshetz</b>: Hi.<br />
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<b>Joni Comstock</b>: Our focus is the severely affected patients, most of who are homebound and bedbound. Some are so sick they’re unable to care for themselves. We were dismayed to learn that the protocol and design for the intramural study has been well underway without any input from the ME/CFS expert clinicians, researchers, as well as from the patient and advocate community.<br />
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This became even more disturbing as so many flaws were revealed about the study. These deficits showed us that many of the ingrained agency misconceptions of the disease still exist and have not been clarified.<br />
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Therefore, we initiated and delivered a petition with 725 signatures to Dr. Collins, to stop the study and start it from scratch with stakeholders input from the get go.<br />
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Because of ingrained institutional misconceptions, whether deliberate or not, we expect the NIH to engage the expert community on any ME/CFS study from the moment of its inception.<br />
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They should have input throughout the entire process. This is includes the planning and implementation of the design, recruitment, trial, analysis, study outcome, peer review publications and the publicity.<br />
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Do you intend to respond directly to MEadvocacy about the petition and how do you plan to incorporate our concerns?<br />
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<b>Dr. Walter Koroshetz</b>: Well let me just start and I appreciate your concerns. And our intent is to reach out and get input from a wide variety of folks with expertise and with experience in this illness.<br />
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And we have been doing that right from the beginning at NIH through the Trans-NIH Working Group, through the CFS Advisory Committee. We’ve had multiple meetings with experts in the field and with advocacy groups. And I must say it has been a challenge for us because there are, well we may not have reached out to everybody.<br />
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And we apologize for that. But it’s been very difficult to know exactly who everybody is and that’s the reason we have these calls and this is not going to be the last of our calls.<br />
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But it’s only the beginning. And we will learn from patients. I think the history of medicine is that as you work with patients, the patients teach you lessons.<br />
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And so, I think that the major teachers at the NIH really have to be the patients who have made the sacrifice to join the protocol, to come into the Clinical Center and to work with the doctors.<br />
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I think that’s where a lot of the input is going to come. And the protocol itself, Brian can correct me if I’m wrong, but the protocol is always a work in progress. So a protocol gets put up. It has to get approved. Then it moves forward.<br />
<br />
Then there are amendments that have to get approved again. Then it moves forward. And the protocol is something that’s going to have to be tested.<br />
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It’ll probably be bringing in control persons to see if they can manage the protocol as it stands before we bring in patients with ME/CFS and put them through the protocol as it stands.<br />
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So I think we are definitely interested in getting input. But in truth of the matter, the scientists at the NIH, they have to be the ones who are empowered to work with their patients to try and get at the bottom of what is the biologic nature of ME/CFS.<br />
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So we are very interested to move ahead and we can’t take all patients with ME/CFS or the very severe cases who are homebound, I think would certainly not be wise to start there. I don’t know - Brian, if you have any points on that.<br />
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<b>Dr. Brian Walitt</b>: You know, part of the protocol is to look at post-exertional malaise which requires pushing patients a bit and being able to exercise and being able to do things.<br />
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Taking a homebound population and stressing them more may lead to untoward consequences for the patients and we need to be concerned about those things. It’s definitely a very important population to study but that might be for the next phase.<br />
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<b>Dr. Walter Koroshetz</b>: Right. And I think, the Clinical Center does have the ability to bring people into the hospital who are in very poor condition because it is a hospital and has 24-hour nursing.<br />
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So it is something that we could potentially get to at some point. But I think it would be probably unwise to start there. So again, I apologize to the community for the perception that we’re not listening because we are very much listening.<br />
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And we will continue to listen and we will continue to communicate best we can. So thank you very much for that. Could I have the next question please?<br />
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<b>Coordinator</b>: Our next question comes from Lily Chu. Your line is open.<br />
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<b>Lily Chu</b>: Hi, good morning. This is Lily Chu. I was one of the co-authors of the IOM Report. I’m also the co-Vice President for the International Association for CFS/ME.<br />
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But my comments today are my own individual views. So I have two points. One is about the study itself and the second is about staff. One of things I found when I was reviewing the literature for post-exertional malaise is a lot of the literature only looked primarily at fatigue as a symptom.<br />
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And I’m trying to review the Web site you have up right now and again, it says that you’re going to have a diary of people recording their symptoms for at least a week once they’re back home.<br />
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And that’s good. But it says fatigue symptoms. So what I would suggest is, you know, PM is more than fatigue. And in our report we talk about things like people having problems thinking, people having problems sleeping, sore throats and enlarged lymph nodes, allover muscle pain.<br />
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So what I would suggest is that you ask for more symptoms than just fatigue and that you leave some open-ended areas where people can put in their symptoms.<br />
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The second thing is timing. So most studies, they just take a period like two days and that’s when they collect their blood tests or their other tests and their symptoms in patients.<br />
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And what I was finding from reading the literature, talking to patients and some data I have that I’m analyzing right now is that timing of PM can vary a lot.<br />
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So ideally, it would be nice if you could time the test to when people are saying this is the peak of my PM or even like have it after one day or two days.<br />
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Because sometimes people’s PM does not start until several days after whatever the triggering event is. In this case, it looks like you’re doing a treadmill to induce the PM.<br />
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So that’s my point about process. The points about staffing, I’m really glad that you have some experienced people on this project, including Dr. Lipkin. But one of my concerns is that you have both Dr. Walitt and Dr. Gill on this staff.<br />
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And I’m sure you’ve heard a lot to some degree already about Dr. Walitt. My concern about Dr. Gill is back in 2011, he did a talk for NIH and he had a lot of slides in there about pacing and about, not about pacing but about graded exercise therapy, cognitive behavioral therapy and about not ordering certain tests.<br />
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Like for example, tilt-table testing because they weren’t suggested by the CDC at the time. And so there are some concerns there -- I can send you links -- where a lot of the community had concerns about Dr. Gill and I even wrote Dr. Gill a letter before his talk.<br />
<br />
I’m hoping his views have evolved and changed since then. So if he’s changed that’s great. But I have a little concern about that. Even if you have the right people for liking the patients, if the people interpreting the studies have certain biases - and we all have biases - but those need to be recognized when they go into and analyze or interpret the study.<br />
<br />
So I’m wondering if the staff that’s on the study, are they going to be reading things like the IOM Report, the NIH Statement of Knowledge Conference Report from 2011 even and the ARC and NIH reports more recently? Thank you.<br />
<br />
<b>Dr. Walter Koroshetz:</b> Thanks very much for that. I’m going to ask Brian to talk a little bit about the protocol with regard to the symptoms you mentioned, the trying to peak, and then the docs working on the protocol.<br />
<br />
<b>Dr. Brian Walitt</b>: So that’s a very good point, that what exactly post-exertional malaise is has been poorly explored to-date. What we’re going to try here at the NIH is to induce it and describe it as it happens.<br />
<br />
This will be done qualitatively by speaking with the patients and listening to what they have to say and hearing their descriptions of it. We may even do a qualitative study of the words that are used to describe it.<br />
<br />
As well as biologic measurements that are taken sequentially starting before the exercise and following it over the course of their hospitalization. And the hope is that we’ll be doing all sorts of different biological measurements to try to capture different aspects of the biology of post-exertional malaise.<br />
<br />
And so your comments about timing are very true and we are taking that into consideration.<br />
<br />
<b>Dr. Walter Koroshetz</b>: Great and thanks for very much.<br />
<br />
<b>Dr. Avindra Nath</b>: Dr. Koroshetz, this is Avi. So, throughout the protocol there will be continued seminar series, journal clubs, so on and so forth.<br />
<br />
So that the team that is working on the protocol becomes well aware of the existing literature, the emerging literature, the pros and cons and the critiques of previous protocols and previous studies as well.<br />
<br />
We’re going to have invited speakers come and talk to us so that we have a cutting-edge knowledge and state of art - the techniques that we are using in order to study the syndrome.<br />
<br />
And that’s how we conduct all our other protocols. So that’s no different than we would do for my other protocols as I would do for this. The other thing is the way I’ve designed the study, there is no element of subjective bias because really what I’m looking for are immune abnormalities, where they’re going to be done in my laboratory, they’re going to be done in the Center for Neuroimmunology.<br />
<br />
And although there are 26 investigators there, there are about, if we include the people in various laboratories and others that are doing the study, there are over 150 people.<br />
<br />
So there is a huge number of people doing things in the study. I ultimately interpret all of these things. And then we will, you know, make the findings available to everybody.<br />
<br />
And there’s an advisory group that looks over our study as well as our findings. So I’m not really concerned...<br />
<br />
<b>Dr. Walter Koroshetz</b>: Right. So Avi dropped off again, but I think the point is that the NIH is a very unusual place in that the people here try and get at the bottom of problems.<br />
<br />
And they have really the strictest scientific minds and I, rarely if ever, have seen what you might call a personal bias affect the study. So I think everybody here is really devoted to just getting to the bottom of the problem.<br />
<br />
And I really do not see any chance that this is going to be corrupted at all. It’s a very unusual place where there’s very little incentive and actually it’s a career-breaker if that ever happens.<br />
<br />
So I really do not feel that this is a concern that the community should worry about. But thanks very much.<br />
<br />
<b>Dr. Avindra Nath</b>: And the design of the protocol is not going to allow any of that anyways.<br />
<br />
<b>Dr. Walter Koroshetz</b>: Yes. Right. Okay. Great. Can we go to the next question?<br />
<br />
<b>Coordinator</b>: Okay. Once again as a reminder to participants to ask a question over the phone lines please press star 1 on your phone and record your name at the prompt. Our next question comes from Jennifer Spotila. Your line is open.<br />
<br />
<b>Jennifer Spotila</b>: Thank you and thank you -- excuse me -- to everyone on the panel, especially Dr. Collins. I appreciate your personal appearance here today. I have as you can imagine a million questions. I’m going to focus on three.<br />
<br />
The first question for Dr. Koroshetz, can you make a commitment to this community today that a request for applications with set-aside funds is going to be part of the short- and long-term strategy coming out of the Trans-NIH Working Group?<br />
<br />
My second question for Dr. Nath or Dr. Walitt is why the selection of Lyme disease as a comparison group? There’s a lot of overlap in the chronic Lyme community and the ME/CFS community.<br />
<br />
People being diagnosed with one when they may have the other and also there’s a question about reliability of the testing. So if you were looking for a post-infectious group with no sequelae, I wonder why something like resolved influenza might not be a better comparison group.<br />
<br />
And then the third question for Dr. Whittemore is how are you going systematically incorporate patient and subject matter expert input into this study and into the formulation of strategy?<br />
<br />
I think these town hall meeting calls are a great tool for you to use but it shouldn’t be the only one. And I know I would really like to see some more systematic involvement of both patients and subject matter experts throughout the phase of the strategy. Thank you.<br />
<br />
<b>Dr. Walter Koroshetz:</b> Thanks very much. Let me talk a little bit about the first question which was the commitment of funds and RFAs. So given the processes I mentioned at NIH, I can’t really say that.<br />
<br />
I can tell you that that’s our goal. That’s what we’re working towards. And we’re hopeful. But I couldn’t say publicly what we’re going to be able to do until we have a plan that we can make public.<br />
<br />
So I hope that’s helpful. In terms of the Lyme disease, Brian would you like to take that one?<br />
<br />
<b>Brian Walitt</b>: Sure.<br />
<br />
<b>Dr. Avindra Nath</b>: I can handle that. This is Avi.<br />
<br />
<b>Dr. Walter Koroshetz</b>: Avi? Okay.<br />
<br />
<b>Dr. Avindra Nath</b>: So the reason I asked for the Lyme disease group is because there’s two reasons for it. Number one is it’s a patient population of convenience for us because Adriana Marques, an infectious disease expert at NIH, has a patient population - she specializes in Lyme disease.<br />
<br />
So she already has a well-characterized population of patients who we know that for certain had Lyme disease and they did get better or they did not get better. And so, we could very easily recruit from an existing cohort.<br />
<br />
And so when we thought about working with these - we want a control population. This is not chronic Lyme disease. So that’s the other thing I want to make absolutely certain.<br />
<br />
These are individuals who had an infection and that they did not develop any other chronic symptoms. They fully recovered. So in that sense that’s pretty close to a healthy normal, because normal individuals also develop infection at some point in time.<br />
<br />
And most healthy individuals recover from it. But here, this is a specific infection, a sample size of individuals that already exists at NIH and we can easily recruit from them. They’ve already been studied at great lengths.<br />
<br />
So we can actually use the information that already exists on them. So with all those things considering that’s why we chose this one. Not that the influenza population is not worthy of studying.<br />
<br />
I think that would be fine too. But we picked this for the reasons that I mentioned.<br />
<br />
<b>Dr. Brian Walitt</b>: If I can also add, the onset of Lyme disease has some very specific physical findings, in particular the rash of Lyme disease that helps us understand exactly when the infection started.<br />
<br />
And so when we’re trying to look at people that are after the infection, it makes it easier to figure out actually when the infection started and pin down the time.<br />
<br />
<b>Dr. Walter Koroshetz</b>: Great. And Vicky, do you want to talk a little bit about engagement of the community as we move towards extramural plans?<br />
<br />
<b>Dr. Vicky Whittemore</b>: Sure. So for the involvement of the community with the Trans-NIH Working Group, we’re thinking about initiating a period of time with each of our working group meetings when we can open the lines and have input and/or potentially presentations from various members of the community.<br />
<br />
Again, using our Web site to push information out and also to get feedback from the community would be really helpful. And I think we’re also always open to any thoughts that the community has.<br />
<br />
We’re thinking about some workshop ideas where we would involve the patient and clinical and research community in the organization and putting that together and also then welcoming patients to attend that meeting.<br />
<br />
I’ll let someone else address, maybe Avi, address involving patients in the intramural study.<br />
<br />
<b>Dr. Avindra Nath</b>: Yes. Can you say that question again about involving patients as advisors or involving...<br />
<br />
<b>Dr. Brian Walitt</b>: Yes, I think she was asking about the patient advisory group Avi. Yes.<br />
<br />
<b>Dr. Avindra Nath</b>: Oh okay. All right. Okay. So we looked into some of the legalities about patient advisory groups and it’s a little bit complicated in the federal government.<br />
<br />
But nonetheless, what we are absolutely committed to is getting input from patients throughout the study itself. So I think some input we’ve already received and we’re going to come up with a system whereby we can get continual input from patients and patient advocacy groups as our study moves forward.<br />
<br />
As Dr. Koroshetz mentioned earlier, the protocol is a process and evolution. Just because you wrote up a protocol doesn’t mean that’s exactly the way it will be conducted.<br />
<br />
There are a lot of changes that occur through the process. And so continual input is necessary throughout the life of the protocol. And so, we’re happy to receive that and we’re happy to work with the patients and the advocacy groups for that purpose.<br />
<br />
<b>Dr. Walter Koroshetz</b>: I think that also the patients who are enrolled are going to have a lot of influence on the docs and how it moves forward. Okay. So thank you very much. Can we go to the next question?<br />
<br />
<b>Coordinator</b>: Our next question comes from Wilhelmina Jenkins. Your line is open.<br />
<br />
<b>Wilhelmina Jenkins</b>: Good morning. I’d like you to especially thank Dr. Walitt for being here. And I understand that Dr. Nath spoke specifically to the importance of keeping personal bias out of any research that goes on.<br />
<br />
But I wonder if Dr. Walitt, just to allay the fears and concerns of the community, could speak directly to that himself. And I’m sure you understand the fears of the community based on many studies that have taken place, particularly the PACE studies in England.<br />
<br />
That we are very concerned about that problem of bias within a study. That is has been shown to affect the results. I understand Dr. Walitt has worked with patients and I would just like to hear him speak again about how his own view of this illness will be incorporated within this study or will not affect this study.<br />
<br />
<b>Dr. Walter Koroshetz</b>: Thanks very much. Brian?<br />
<br />
<b>Dr. Brian Walitt</b>: First let me affirm by saying that Chronic Fatigue Syndrome, Myalgic Encephalomyelitis is a biological disorder. Research has shown that in every system of the body that has been investigated that there have been abnormalities when compared to healthy volunteers.<br />
<br />
<span style="color: #cc0000;"><b>If Chronic Fatigue Syndrome, Myalgic Encephalomyelitis is all in your head, it’s only because your head is part of your body. In regards to my individual role in this study, I am certainly a facilitator of research hoping to coordinate all the scientists and all the medical professionals that we require to make this happen and to help provide care and to be a cheerleader for the patients as they come through the protocol.</b></span><br />
<br />
<span style="color: #cc0000;"><b>I don’t have a bias and I don’t have the outcome that I hope to see except that we find an answer that makes people better.</b></span><br />
<br />
<b>Dr. Walter Koroshetz</b>: Great. Thank you very much Brian.<br />
<br />
<b>Marian Emr</b>: We have time for one last question.<br />
<br />
<b>Coordinator</b>: Okay. It’ll just be one moment.<br />
<br />
<b>Marian Emr</b>: Then let me just fill the gap by saying I know there are others of you waiting to ask questions of us. Please, thank you for your participation this morning. And send us those questions.<br />
<br />
Please send your questions to braininfo@ninds.nih.gov and we will make our best effort to respond to you in a timely manner. Thank you again for participation. One last question.<br />
<br />
<b>Coordinator</b>: And our final question comes from (Deborah Waroff). Your line is open.<br />
<br />
<b>Coordinator</b>: We’ll skip to the next question. The final question comes from Rivka Solomon. Your line is open. Rivka, you currently have an open line.<br />
<br />
<b>Rivka Solomon</b>: Hi, sorry I was on mute. Sorry. Can you hear me now?<br />
<br />
<b>Dr. Walter Koroshetz</b>: Yes, very well. Thank you.<br />
<br />
<b>Rivka Solomon</b>: Okay. Thanks. Thank you very much for holding this meeting today. So I’ve been sick 26 years, much of that homebound and bedridden. And it’s obviously devastated my life and at least a million other patients are suffering with this illness in this country.<br />
<br />
I think that we need equitable research funding at a level that’s commensurate with the degree of disability and with the population numbers. I know this is a first step you’re saying, but in my mind and in many patients' minds we need probably something along the lines of $250 million a year to be able to address this illness properly.<br />
<br />
And that doesn’t even count the 30 or so years that we’ve missed. So could somebody address that please?<br />
<br />
<b>Dr. Walter Koroshetz</b>: Thanks Rivka. Yes, I think for this as unfortunately as well as many diseases, the amount of research funding does not match the burden of illness. In our institute, we have probably 300 different neurologic diseases.<br />
<br />
And that’s the case for every single one of them. <b><span style="color: #cc0000;">That being said, the process by which NIH deals with how to allocate these scarce resources is a tried and true process that’s been in place for 50 years where investigators submit grants, they get peer reviewed and they get scored</span></b>.<br />
<br />
And then the NIH starts to pay the ones that seem to be the most highly meritorious and go down the list until we run out of money. So the system is a peer review system and what we need in some diseases and I think in ME/CFS, we need funds to formalize the research, to get the research going.<br />
<br />
To get really a large number of highly motivated and well trained investigators into the field, and that’s what we are planning to do in the fairly short time, is to try get that growth of investigators.<br />
<br />
<span style="color: #990000;"><b>But the truth of the matter is to really get the funds towards ME/CFS to a higher level on par with many other like-diseases, we need those kinds of applications to come in and compete against -- and in a fair way -- with the other disorders.</b></span><br />
<br />
And so I think as a short-term process that we definitely have to stimulate with funds that are particularly for ME/CFS and Dr. Collins is clearly behind that. But our hope is that this will actually spread.<br />
<br />
That the community will come in and begin working with investigators at universities and clinics throughout the country.<br />
<br />
And that groups will form that will submit applications that are clearly incredibly important and a high level of science that gets to the bottom of the problem.<br />
<br />
So I think, again, we have to utilize the NIH resources as best we can for the long-term and I think we can do that. But we cannot do it alone. We need to do it with the patients and the advocacy groups together, working hand in hand as we try and fight this illness. So I want to thank everyone for coming on.<br />
<br />
We’re out of time. We will certainly be looking at the questions that get submitted and we will, again, set up another call where we can continue the dialogue that we started today.<br />
<br />
And I can’t say how much everyone around the table and Dr. Collins appreciates the interest and the concerns of the community. It’s really been fantastic. So thanks very much.<br />
<br />
<b>Marian Emr</b>: Please send any of your unanswered questions to braininfo@ninds.nih.gov. And for those of you who aren’t near a pencil and paper, you can go to the main NIH ME/CFS Web site and simply click on contact us to submit those questions. Thank you again for a very productive discussion this morning.<br />
<br />
<b>Coordinator</b>: Thank you for your participation in today’s conference. You may now disconnect.<br />
<br />
END</div>
</div>
Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-11783540287440630622016-03-11T04:02:00.000-08:002016-03-11T15:21:42.296-08:00NIH Study: Foxes Guarding the Henhouse<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjrt06pUM9CmtOqT1ULU5hMAOVWFrtyk_otr2Z1wgSVFUJ5wEo_xPYFH3ZIKkxPK2ZCW6qUtxYpsVWe3Zy9BLemgj8sahw-Bd5g6Cy77n-vYVY5gNDTW6vflTXcYChR5IIVoYnNBwXHvtA/s1600/fox.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="284" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjrt06pUM9CmtOqT1ULU5hMAOVWFrtyk_otr2Z1wgSVFUJ5wEo_xPYFH3ZIKkxPK2ZCW6qUtxYpsVWe3Zy9BLemgj8sahw-Bd5g6Cy77n-vYVY5gNDTW6vflTXcYChR5IIVoYnNBwXHvtA/s400/fox.jpg" width="400" /></a></div>
When the NIH posted the protocol for its study on ME/CFS, it was immediately met with a storm of protest.<br />
<br />
First, the protocol used the discredited Reeves (aka Empirical) case definition to establish its cohort of patients.<br />
<br />
Second the tests seemed vague and far too general, as if the NIH were going on a fishing expedition rather than employing a focused approach.<br />
<br />
Third, there was no mention of tests that would indicate that the staff was well versed in research performed outside the purview of the CDC. (The protocol has since been removed.)<br />
<br />
In spite of Dr. Collins' repeated assurances that the NIH is taking ME/CFS research "very seriously," the FAQs posted on the NIH site (read them <a href="http://mecfs.ctss.nih.gov/faq.html" target="_blank">HERE</a>) do little to allay the concerns of the community.<br />
<br />
<b>Walitt and Gill: Inherent bias</b><br />
<br />
Most disturbing, there is the question about the Executive Board of "clinical experts" chosen to oversee the selection of patients. This Board consists of Dr. Elizabeth Unger, Dr. Ian Lipkin, Dr. Leorey Saligan, Dr. Fred Gill, and Dr. Brian Walitt. While some of these Board members have been involved in research, not one of them has clinical expertise in diagnosing ME/CFS.<br />
<br />
A further concern is NIH's appointment of Dr. Brian Walitt to be Clinical Director for the ME/CFS study. Dr. Walitt's views on fibromyalgia were presented in an interview he gave last September at the Perspectives in Rheumatic Diseases conference, held by Global Academy for Medical Education.<br />
<br />
Dr. Walitt's interview, while meandering, clearly stated that he considers fibromyalgia, and similar disorders (such as ME/CFS) to be psychosomatic conditions, that is, symptoms which are generated in order to compensate for emotional or psychological upset. (Please read Jeannette Burmeister's post <a href="http://thoughtsaboutme.com/2016/02/21/brian-walitts-radical-bias-disorders-of-subjective-perception-mecfs-as-normal-life-experience/" target="_blank">Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?</a> for an in-depth analysis of Dr. Walitt's interview.)<br />
<br />
According to Dr. Walitt's interview, the pain experienced by people with FM is "normal,"<br />
<br />
"These atypical things," he said, "are just a range of normal, that you are not sick, bad or weak, that you are just dealing with the difficulties of just being a human."<br />
<br />
Dr. Walitt went on to say that there is no treatment for FM, therefore patients should "carefully consider changing their life narrative." (Practitioners of CBT call this "correcting false illness beliefs.")<br />
<br />
While an interview may be subject to interpretation, the written word is not. In 2013, Dr. Walitt co-authored a paper with Dr. Frederick Wolfe, entitled "<a href="https://www.arthritis-research.org/files/Wolfe%20(2012)%20Culture,%20science%20and%20the%20changing%20nature%20of%20fibromyalgia%20-%20NRR%20submission%20version.pdf" target="_blank">The Changing Nature of Fibromyalgia</a>." In that article he clearly expresses the view that FM is a "psychocultural" construct. He lays the blame for turning FM into an "illness" on rheumatologists, politicians, the "legal industry," and, most significantly, patient groups.<br />
<br />
The psychogenic viewpoint is also expressed in another article published in 2013, "<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3720238/" target="_blank">Gene expression profiles of fatigued fibromyalgia patients with different categories of pain and catastrophizing: A preliminary report</a>" as well as a more recent 2016 article,"<a href="http://www.ncbi.nlm.nih.gov/pubmed/26743156" target="_blank">Quantifying the influence of child abuse history on the cardinal symptoms of fibromyalgia</a>."<br />
<br />
"The experience of child abuse," he concludes, "is associated with FM symptom severity and may shape the biological development of interoception in ways that predispose to pain and polysymptomatic distress."<br />
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In short, Walitt believes that emotionally unsound, middle-aged women exaggerate normal symptoms (such as pain) but that they have somehow convinced the medical and legal establishment that they have a "real illness" to justify their mistaken belief that they are ill. The remedy? They should learn to live with it.<br />
<br />
Unfortunately, Dr. Walitt isn't the only member of the Executive Board to adhere to psychogenic explanations of ME/CFS. In a 2011 lecture held at the NIH, "Chronic Fatigue Syndrome: Is there a virus?", Dr. Gill expressed the view that ME/CFS could be successfully treated with exercise (GET) and therapy (CBT). (You can read the Mass CFIDS/ME and FM Association's summary of his lecture <a href="https://www.masscfids.org/more-resources-for-me-cfs/295-summary-and-comments-on-the-nih-videocast-qdemystifying-medicine-cfs-is-there-a-virusq" target="_blank">HERE</a>.) Like Dr. Walitt, he compared ME/CFS to neurasthenia, a 19th century psychiatric disorder thought to be the product of overwork and "stress."<br />
<br />
The inclusion of two staff members who do not believe in the biological underpinnings of ME/CFS on a project professing to <i>identify</i> biological underpinnings is absurd. Their predisposition to <i>ignore </i>biological evidence has already been amply demonstrated in their presentations, talks, and papers. How can the NIH seriously consider including these two men on this study?<br />
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I have written to the NIH requesting that both of these men be removed (see below). Please feel free to write the NIH yourself, and to use my letter as a template.<br />
<br />
Address your letter to: braininfo@ninds.nih.gov<br />
<br />
____________________<br />
<br />
<br />
Dear Dr. Koroshetz,<br />
<br />
I have read about the NIH ME/CFS research study with great interest. This study is important, not just for identifying the cause of ME/CFS, but for all future research, and therefore must be designed and conducted with the greatest of care.<br />
<br />
Dr. Nath has expressed the opinion that because so many people are involved in this study individual bias would be impossible. However, on your research study FAQs, you list Dr. Gill and Dr. Walitt as two of five staff members who will make final assessments of diagnostic validity.<br />
<br />
Dr. Gill has gone on record as recommending graded exercise (GET) and cognitive behavioral therapy (CBT) for patients with ME/CFS. Both of these treatments stem from the "psychosocial" model held by psychiatrists who believe ME/CFS to be a form of hysteria ("conversion disorder"). Dr. Gill has also compared ME/CFS to neurasthenia, a 19th century disorder that bears only passing resemblance to ME/CFS and is widely considered to be a form of anxiety.<br />
<br />
Dr. Walitt has professed a similar view of fibromyalgia and its related illnesses (e.g. ME/CFS). In a paper published in 2013, he stated that “Fibromyalgia does not fit the definition of a categorical disorder, but represents the end point of a continuum of polysymptomatic distress. The evidence for a psychocultural disorder is strong.” He has stated in clear terms that patients experiencing the pain of FM are simply exaggerating "normal" symptoms, and that they should change their "life narrative" rather than seek treatment.<br />
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As staff members making final assessments of diagnostic validity, Dr. Walitt and Dr. Gill are in a position of relative power and authority over other staff members and investigators. Their view on the illness as being psychogenic will undoubtedly influence their decisions. Both are biased and should not be involved in this project.<br />
<br />
<br />
Sincerely,<br />
<br />
Erica Verrillo, PatientErica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-70363844275055957752016-03-09T05:12:00.004-08:002016-03-09T05:21:05.644-08:00CDC Grand Rounds: Chronic Fatigue Syndrome: Advancing Research and Clinical Education, Part II<div class="separator" style="clear: both; text-align: center;">
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<i>This post first appeared on <a href="http://www.prohealth.com/library/showarticle.cfm?libid=27067" target="_blank">ProHealth</a></i>.<br />
<br />
Transcript by Erica Verrillo<br />
<br />
On February 16, 2016, the CDC hosted a one-hour session on ME/CFS. Featured speakers included Dr. Charles Lapp, Dr. Beth Unger, Dr. Anthony Komaroff, and Dr. Avi Nath. The session was introduced by Dr. Harold Jaffe, CDC Associate Director for Science.<br />
<br />
This second part of the session consists of a presentation by Dr. Avi Nath, the neuroimmunologist who is heading the NIH study on ME/CFS. The last 10 minutes of the session was opened to questions from the floor, during which Dr. Nath supplied more details about the study. <br />
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Main points in Dr. Nath's presentation:<br />
<br />
<b>Phase I</b> of the trial will involve 40 patients. This will be an in-depth study, and will take about a year. NIH hopes to discover the pathophysiology of ME/CFS during this period and discover biomarkers. Tests will include an exercise test to induce PEM, MRIs, cerebrospinal fluid tests, including a screen for autoantibodies to neural antigens, and an exploration of the gut and oral microbiome applying proteomics and metabolomics approaches.<br />
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<b>Phase II </b>of the trial will be open to a larger group of participants. This phase will validate biomarkers found in Phase I.<br />
<br />
<b>Phase III</b> of the trial will focus on immunomodulatory agent, such as Ampligen, which can target the biomarkers found in Phase I.<br />
<br />
Some questions raised by the audience concerned how NIH would incorporate patient input, what steps were being taken to educate physicians and medical students, and what kind of immune tests would be performed.<br />
<br />
<i>You can watch a video of the entire session <a href="https://www.youtube.com/watch?v=0SnJy5AOSd8">HERE</a></i>.<br />
<br />
<i>You can see the slides that accompanied the four presentations <a href="http://www.cdc.gov/cdcgrandrounds/pdf/archives/2016/feb2016.pdf">HERE</a></i>.<br />
<br />
<i>You can read FAQs about the study </i><a href="http://mecfs.ctss.nih.gov/faq.html" target="_blank"><i>HERE</i>.</a><br />
<br />
<i>You can read about the Grand Rounds' first three presentations here</i>: <a href="http://cfstreatment.blogspot.com/2016/03/cdc-grand-rounds-chronic-fatigue.html" target="_blank">CDC Grand Rounds: Chronic Fatigue Syndrome: Advancing Research and Clinical Education, Part I</a><br />
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<b>Dr. Avi Nath</b>
[42:38]: As some of you know, the National Institutes of Health has had a
long-standing interest in chronic fatigue syndrome. In December of 2014, NIH
sponsored a Pathways to Prevention workshop to advance research on ME/CFS. In September of 2015, Dr. Francis Colllins,
the director of NIH, tasked the intramural program to develop a research
protocol to study the illness using the unique resources that are available at
the intramural program. </div>
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The relationship to infections to the onset or ME/CFS and
the large body of literature identifying a variety of interesting but
inconsistent immune abnormalities in these patients provide a rationale for
further studies of immune regulation. For example, two studies from a group in
Norway showed delayed clinical improvement in patients following treatment with
rituximab, which is a monoclonal antibody that depletes B cells. However, these
studies were small, and the immune profiles were not measured in these
patients.</div>
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Patients with ME/CFS can be associated with a variety of precipitating
factors. Our studies will be focused on a defined subset of patients who have a
viral illness at onset of their illness. These patients are likely to have
quite similar immune profiles. Our hypothesis is that post-infectious ME/CFS is
triggered by a viral illness that results in immune-mediated brain dysfunction.
To address this we have proposed a three-phase study. </div>
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The first phase is a cross-sectional study which will define
the phenotype and pathophysiology of the disease. Phase two will validate the
biomarkers in a longitudinal study. And phase three will be an early
intervention trial to target the biomarkers identified in phase two. </div>
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The first aim of the phase one study is to define the
clinical phenotype using in-depth assessments of all domains of the illness.
[slide] Aim two of the study is to define the physiological basis of fatigue
using functional MRI scan of the brain to define the brain circuits involved;
do detailed metabolic studies in a metabolic chamber, and so transcranial magnetic
stimulation as well as very detailed autonomic testing. Each of these tests
will be performed before and after exercise. <br />
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The third aim of the study is to conduct a detailed
immunological study in blood as well as cerebrospinal fluid, including a screen
for autoantibodies to neural antigens. We will also fully explore the gut and
oral microbiome and apply proteomics and metabolomics approaches to the
cerebrospinal fluid. </div>
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The fourth aim of the study will utilize a variety of novel
approaches to explore whether cells or serum from patients can be used to
experimentally reproduce some of the features of the illness. We will determine
if there is an inherent metabolic abnormality in neurons derived from stem
cells and culture from these patients and if exposure of spinal fluid will
induce the functional abnormalities in these cells. </div>
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We will also generate humanized mice using blood cells and
determine if the clinical phenotype can be reproduced in these animals. If these experimental systems are able to reproduce
the clinical or biologic abnormalities seen in these patients, it would be a
major step towards identifying the cause and the pathophysiology of the
illness, and for developing a variety of treatment approaches to these
patients. </div>
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For the purpose of our phase one study, we plan to recruit
patients primarily from well-characterized cohorts, particularly the CDC’s MCAM
study. Selection criteria will include
documentation of the acute onset and duration of fatiguing illness for more
than six months but less than five years. All patients will have
post-exertional malaise and full criteria of the 1994 research case definition
and the Canadian Consensus Criteria. The study population will include 40
post-infectious ME/CFS patients, 20 healthy controls, 20 post-Lyme patients who
are asymptomatic, that means they do not have fatigue, and 20 patients with
functional movement disorders.</div>
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These studies are still being refined and rely on the talent
and expertise of a large number of investigators listed here. I would
particularly like to thank Dr. Brian Walitt, who is the lead clinical
investigator of this study at NIH and Drs. Unger and Lipkin as members of the
executive committee for their valuable advice.</div>
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<b>Q&A</b> [49:36]<br />
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<b>Q</b>: Why isn’t the
CDC/NIH as a whole bringing pressure to bear on researchers and educating
treating physicians to use far more extensive and detailed survey instruments
and be far more precise in their description of the symptom presentation and
pathogenesis?</div>
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<b>Unger</b>: I think
that we are publicizing the importance of using instruments to precisely
characterize the illness and we are in the process of publishing the baseline
results of the MCAM study which will absolutely specify the instruments we are
using and how they can help in other studies. And I believe we have been
working with NIH and we are going to be sharing a lot of the same instruments
and approaches.</div>
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<b>Nath</b>: We are
delighted to be able to share whatever information we have and to work very
closely with the CDC as Dr. Unger mentioned to achieve those goals. </div>
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<b>Q</b>: Another of our
viewers would like to know all the specific steps that are being taken to
educate medical students in medical schools using the latest information from
that 2015 Institute of Medicine ME/CFS report.</div>
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<b>Unger</b>: Okay,
well, we are… we have just started our medical student curriculum, as I
mentioned through the MedEdPORTAL. This incorporates … so we started it before
the 2015 but the educational curriculum that goes along with it gives the
references from the IOM – the IOM report. In addition we have our collaborative
process ongoing … or it’s just being started where we are trying to work with
medical educators to find out what kind of materials they want and can easily
incorporate into their classes. The advantage of the MedEdPORTAL is that it is
online and it is free for faculty and actually medical students actually can
have access to it as well. So we think that will be a useful start. The collaborative work group is what we hope
will also be giving us advice as to what would be most helpful. </div>
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<b>Q</b>[Wilhemina Jenkins]: Dr. Nath,
could I ask you to be a little more detailed about the patient advisory
committee, how you intend to incorporate patient input into the NIH study? And
could I also ask, I don’t know if you have the answer to this, about external
funding from NIH to other researchers on the outside, possibly through RFAs
that might be developed.</div>
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<b>Nath</b>: So, firstly
I think input from the patients is absolutely critical for any disease that you
want to study. They are ones who really experience the symptoms and live it –
live it from day to day. As physicians whatever input we can get from patients
is very important to whatever mechanism it is. Any physician will tell you that
you learn a lot more from talking to patients than you do from reading any kind
of textbook, journal, or whatever medical literature that is available. Careful
listening to patients is absolutely critical. What that in mind, I grew up in
the early AIDS epidemic , and I saw interactive with Act Up, and other patient
forums whereby they had a great impact on the way the disease was handled,
treated and moved the Federal government to make changes at every level. And
so, we understand the importance of it, and there are efforts under way to put
that advisory group together. So, you know, people who are senior to myself
want to look at it from all perspectives and put together a proper group that
will address both intramural and extramural teams. I think those efforts are
under way and we are looking forward to that input. </div>
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With regards to external funding, again, that is beyond my
area of authority and so I know there is a lot of interest in being able to
make that happen. A lot of advocacy groups have approached NIH with that
effort. I think the heart is in the right place and all those things will be
done. I think it’s probably just a matter of time before you see all these
things happen. But there is no lack of interest in achieving those goals. </div>
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<b>Q</b>: I'm Steve Monroe,
Associate Director for Lab Science and Safety. I have a question for Dr. Nath.
Given the consensus of the role of immune dysregulation and the symptoms of the
disease, can you elaborate a little bit on the kind of functional immune assays
that you are projecting to do with the upcoming study.</div>
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<b>Nath</b>: I’ve put
together a panel of really outstanding immunologists to guide me. Although I do
consider myself to be a neuroimmunologist, every immunologist is not the same.
There are people who specialize in B-cells, and T-cells, and NK cells, and so
on and so forth. So what I did was I called on Dr. Neal Young, who is an expert
immunologist at NIH and Ronald Germain, who is a National Academy of Science
member, and so we sat and discussed various kinds of things. I think what we’re
going to do is we’re going to collect a lot of lymphocytes both from blood and
from CSF [cerebrospinal fluid]. Initially, we’ll be storing them and what we’ll
be doing is looking at cell-free fluid in the CSF and the serum for not just a
small number of cytokines, actually 1,500 lysates, analytes. But we want to be
very comprehensive and I have developed a proteomics assay in my own lab which
will look at about at least 2,500 proteins. So when we look at the composite, I
think that it will be very clear to us what cell types may be dysfunctional in
these patients and how we can subgroup those individuals, and that will then
allow us to go back and say, well, this looks like an NK cell function, let’s
look at it, or this looks like a B-cell, because there are innumerable amounts
of very time-consuming tedious assays for each cell type that you could
potentially do on interactions between cell types. Instead of doing that at the
get-go and everything you could possibly think , I think that’s a good
screening tool, and then we can focus on the real aspects that we think are
really dysfunctional. </div>
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<b>Q</b>: Do you think
primary care providers can offer appropriate services to chronic fatigue
patients or would it better for them to refer to specialists? </div>
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<b>Komaroff</b>: Yes, I
think primary care providers can provide adequate services, particularly if
they have people in ID, neurology backups when something doesn’t add up. But
primary care providers need to be better educated than most are currently. </div>
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<b>Lapp</b>: I would
agree with that and as a primary provider myself, and former family physician
and internist and pediatrician, we’re at the forefront. The family physicians,
the family doctors, are the ones who really see the majority of these cases
first, not the specialists. So, as Tony [Dr. Komaroff] has pointed out it’s
very important for these providers to be educated and know how to recognize the
patients when they walk in the door. I should point out from previous studies
done by the CDC that not only the primary providers but also the mid-level
providers are doing a lot of the diagnosing and initial treatment of patients
too. I think it is very important to
address that group of individuals. </div>
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I would like to say that since the IOM report came out and
the P2P, that we’ve seen a great deal of movement from the government. The patients
always want to hear that, that there is something being done. From my
perspective, working with this wonderful group, I’ve seen a lot of movement on
behalf of the CDC and the National Institute [sic] of Health and even some
positive statements from Dr. Francis Collins, who seems to be supporting a
movement for more research into chronic fatigue syndrome. </div>
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<b>Q</b>: I’m Brenda
Robertson, and I’m a nurse at Emory and Grady. My background is community
health and divinity. And I want to know if there is anyone at the CDC or NIH or
beyond looking at research into environmental triggers, such as the chemical
loads that have been added to the food industry since the ‘70s and ‘80s, like
phosphates, fructose, citric acid, and I wonder if anyone’s looking at that as
serious triggers because this is a widespread illness.</div>
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<b>Unger</b>: We don’t
have a specific focus on that. We are aware that there are environmental
triggers in some patients, but it is something that we have in mind, but we
don’ t have an active program in that right now.</div>
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<b>Nath</b>: At the
intramural program we don’t have that kind of expertise. Our focus will really
be on immune dysfunction. But the sample will certainly be stored. Once the extramural
community gets involved, that have expertise in those areas, we would be
delighted to work with them and provide them whatever resources we have in
patient samples.</div>
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<i>END PART II<o:p></o:p></i></div>
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Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.comtag:blogger.com,1999:blog-6446254168150227367.post-87202054260271771292016-03-07T03:56:00.003-08:002016-03-09T05:15:39.100-08:00CDC Grand Rounds: Chronic Fatigue Syndrome: Advancing Research and Clinical Education, Part I<div class="MsoNormal">
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Last month's CDC Grand Rounds on Chronic Fatigue Syndrome featured presentations by Dr. Charles Lapp, Dr. Elizabeth Unger, Dr. Anthony Komaroff, and Dr. Avindra Nath. A short Q&A session followed the final presentation.<br />
<br />
The full transcript of Part I is below. I have begun with a brief summary of the first three speakers, including my commentary.<br />
<br />
You can read Dr. Nath's presentation as well as the Q&A session that followed the presentations here:<br />
<a href="http://cfstreatment.blogspot.com/2016/03/cdc-grand-rounds-chronic-fatigue_9.html" target="_blank">CDC Grand Rounds: Chronic Fatigue Syndrome: Advancing Research and Clinical Education, Part II</a><br />
____________________<br />
<br />
<i>Dr. Charles Lapp</i><br />
<br />
Dr. Lapp's talk centered on the presentation of the illness, which he characterized as abrupt (developing over a few hours or days), with waxing and waning progression, and usually following an infection. He stressed that the disease could be devastating in its severe form, and frequently occurred with comorbidities. To diagnose the disease, Dr. Lapp recommended taking a complete history, including "psychosocial factors," as well as ruling out overlapping illnesses with exclusionary tests.<br />
<br />
Dr. Lapp did not cover treatment, but rather presented his "four pillars of management": Education, Behavioral modification, Pharmaceutical management of symptoms (such as antidepressants), and Non-pharmaceutical interventions (such as exercise).<br />
<br />
In this final section of his talk, Dr. Lapp's suggestions fell afoul of the observations of many patients, as well as other expert physicians. Intolerance of antidepressants, especially the tricyclics, has been noted by specialists, including Dr. David Bell, whom Dr. Lapp cited in his presentation. According to Dr. Bell, a bad reaction to tricyclic antidepressants was virtually diagnostic of ME/CFS. Antidepressants have also been the most consistently negatively rated class of pharmaceuticals in several patient surveys, including a large survey conducted by the ME Association, and a smaller survey conducted by ProHealth.<br />
<br />
Dr. Lapp's recommendation of graded exercise also flies in the face of patient experience. There is no evidence that graded exercise benefits ill patients, and plenty of proof that it causes harm. Yet doctors, some of whom should know better, seem to feel that by not taking exercise their patients will get worse. Dr. Lapp's suggestion to "begin with five minutes" of exercise makes very little sense, because a patient who cannot spontaneously walk for five minutes is certainly too ill to begin any exercise program, however innocuous seeming. This was a disappointing end to an otherwise good overview of the disease.<br />
<br />
____________________<br />
<br />
<i>Dr. Elizabeth Unger</i><br />
<br />
The next presentation was by Dr. Unger of the CDC, who reviewed some facts about ME/CFS, based on the CDC's own studies. Because she did not draw on outside sources, her portrayal of the disease was somewhat skewed. For example, Dr. Unger stated that "compared to healthy controls, persons with CFS had more exposure to significantly more stressors and are likely to have a higher allostatic load, that is, a measure of the physiologic consequences of chronic neuroendocrine response to stress."<br />
<br />
The "stress" theory was one espoused by Dr. Stephen Straus, and by others who adhere to "psychosocial" models of causation. However, the assessment of pre-illness "stress" in ME/CFS patients is retrospective, which means it is inherently unreliable. The only reliable way to gauge "stress" as a factor in the development of an illness is to start with a population that is unstressed, introduce "stress," and see how many develop the disease. Until that is done for ME/CFS, "stress" cannot be included as an etiological factor.<br />
<br />
The claim that "stress" plays a role in the development of ME/CFS is also contradicted by Unger's own study, which found that ME/CFS patients are as emotionally and psychologically sound as healthy controls, <i>in spite of being very ill</i>. If stress were a significant factor in the development of the illness, how is it that ill patients - who are the most stressed of anyone - are able to cope so well?<br />
<br />
____________________<br />
<br />
<i>Dr. Anthony Komaroff</i><br />
<br />
The third presentation was by Dr. Komaroff. He was asked to briefly summarize the IOM report, the P2P workshop, and the AHRQ review.<br />
<br />
Dr. Komaroff stressed that the reports had found considerable evidence that ME/CFS is a biological illness. The IOM panel concluded that “ME/CFS is a serious, chronic, systemic disease that often can profoundly affect the lives of patients” and that ME/CFS is not, as many physicians believe, a psychological disorder.<br />
<br />
The P2P report concurred in this and called specifically for research on the possible role of herpes viruses in ME/CFS. He then described the IOM's new case definition for SEID. (Scroll down to Dr. Komaroff's presentation to see the slide.) Although Dr. Komaroff did not dwell on the AHRQ report, he did mention that it stressed the need to test the IOM's case definition before adopting it.<br />
<br />
In his discussion of the IOM's new case definition, Dr. Komaroff touched on the origins of both the original case definition proposed by the CDC and the name, chronic fatigue syndrome. "As a member of that group," he said, "I would note that we were all focused on developing a case definition. No one really thought about the name, and when someone proposed the name chronic fatigue syndrome, people said 'Why not?' That was a big mistake."<br />
<br />
Dr. Komaroff's review of the IOM report was thorough and accurate. However, he made an interesting comment when discussing the case definition for SEID. He said it was "shorter and simpler" (then contradicted himself by saying it was <i>not</i> simple), but that it was "the best we can do."<br />
<br />
In light of the long track record held by the CCC, it is puzzling that Dr. Komaroff should say the SEID case definition is "the best we can do." (Obviously, experts in this illness have already done better.) By all accounts, the case definition for SEID is far too simple, and likely to include people with a number of other illnesses (including depression). Perhaps, Dr. Komaroff's apparent blind spot concerning the CCC was due to his involvement with the devising the original CDC case definition, which has since proved inadequate.<br />
<br />
_______________________<br />
<i><br /></i>
<i>You can view a video of the entire session <a href="http://www.youtube.com/watch?v=0SnJy5AOSd8" target="_blank">HERE</a></i>.</div>
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<i>You can see the slides that accompanied the four presentations <a href="http://www.cdc.gov/cdcgrandrounds/pdf/archives/2016/feb2016.pdf" target="_blank">HERE</a></i>.<br />
<br />
<i>This transcript was first published on <a href="http://www.prohealth.com/library/showarticle.cfm?libid=26966" target="_blank">ProHealth</a></i>.<br />
<br />
____________________</div>
<br />
<b>CDC Grand Rounds: Chronic Fatigue Syndrome: Advancing
Research and Clinical Education </b></div>
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<br /></div>
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Transcript by Erica Verrillo</div>
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<br /></div>
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On February 16, 2016, the CDC hosted a one-hour session on
ME/CFS. Featured speakers included Dr. Charles Lapp, Dr. Beth Unger, Dr.
Anthony Komaroff, and Dr. Avi Nath, who is heading the NIH study on ME/CFS. The session was introduced by Dr. Harold
Jaffe, CDC Associate Director for Science.</div>
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<br /></div>
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<b>Dr. Jaffe</b>: Chronic
Fatigue Syndrome is an important public health problem. Though many questions
about the disease remain to be answered, we know that the disease is real, and
that patients suffer greatly. Furthermore the economic impact of the disease is
felt across the country. Chronic Fatigue Syndrome is a biologically based
illness that affects individuals in nearly all aspects of their lives,
significantly affecting their ability to work and support their families.
Sadly, studies show that patients experience significant barriers in terms of
receiving appropriate health care. This needs to change. We need to enable
health care providers to better recognize and offer treatments for this
condition. </div>
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<br /></div>
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Today we will learn that while there is no cure, there are
management and therapeutic advances that can help patients. We need biomarkers to help make the disease
more clearly diagnosable. We are aware that just the name “chronic fatigue
syndrome” is imperfect in many ways, and can be unhelpful to clinicians and patients.
However, we should not let legitimate arguments about nomenclature impede our
scientific progress. CDC’s approach to reducing CFS morbidity includes working
partnerships with clinical research experts, patient advocacy groups and other
governmental agencies. At a time of unprecedented attention to this profoundly
disturbing condition, CDC is committed to the broad outreach and clinical
education efforts, of which this session is just one part. Again, the message
is CDC is in this for the long run, we are not going to wait. <br />
<br />
____________________<br />
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<b>Dr. Charles Lapp</b> [4:23]: Let me start by saying that in 1991
one of my colleagues, David Bell, wrote a book entitled “The Disease of a
Thousand Names.” That title exemplifies the confusion we have about this
illness. The signs and the symptoms are so general and so diverse, that chronic
fatigue syndrome mimics many other disorders and has earned numerous monikers
over the years, including Royal Free Disease, Iceland Disease, Tapanui Flu,
“Yuppie Flu” (by the way, that came from the eminent medical journal, Rolling
Stone Magazine), Myalgic Encephalomyopathy, Chronic Fatigue and Immune
Dysfunction Syndrome, SEID (Systemic Exertion Intolerance Disease). For this
presentation, I will be using the more common name chronic fatigue syndrome,
which was chosen because 100% of the study’s subjects experienced an unusually
severe and persistent type of fatigue. </div>
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<br /></div>
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There is no explanation why individuals contract chronic
fatigue syndrome, but we do know that the majority of cases occur acutely over
hours to days, and typically follow a bacterial or viral-like illness. <br />
<br /></div>
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Let me introduce you to a typical case. This is an actual
clinical case from my practice. </div>
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<br /></div>
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Jane was a 37-year old internet technologist for a community
bank. She had been physically active in sports and had been working out and had
been maintaining her own household when she contracted a flu-like illness in
2011. She was bedbound at first, and very slow to recover. Within days she
noticed an unusual fatigue after minimal activities, then insomnia, then
achiness in the joints and generalized muscle pain and weakness.<br />
<br />
She soon found
it difficult to recall recent conversations and events. Reading concentration
was limited and she had trouble comprehending what she had read, or seen on TV.
She would search for words, lose her train of thought, and friends would
sometimes have to finish sentences for her.
Sleep had always been good but now she was restless at night, and would
awaken unrefreshed, even after many hours of bed rest.<br />
<br />
She felt stiff and sore
and foggy, and for an hour or two after awakening, she noticed dizziness or
light-headedness on getting up quickly. On a couple of occasions she saw stars,
but no tunnel vision and no syncope. Now she was unable to keep up the house,
and she had to rely on friends and family to help her with the cleaning,
laundry, and shopping.<br />
<br />
She would attempt to keep up at home and at work, but
exertion would inevitably make the symptoms worse, and if she exerted too much
she would end up sick and chair bound for one or two days afterward. An evaluation
by her primary care physician revealed rather low blood pressure, but there was
no immediate orthostatic blood pressure drop and otherwise the examination was
unremarkable. Blood work was unremarkable.<br />
<br />
Having no explanation for her
symptoms, despite the profound reduction in her physical abilities, Jane became
anxious about her future and frustrated and discouraged as well. </div>
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<br /></div>
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This clinical case demonstrates all the key features of CFS:
</div>
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<br />
<ul>
<li>Exertion intolerance and debilitating fatigue</li>
<li>Post-exertion relapse and malaise</li>
<li>New onset of sleep problems</li>
<li>Cognitive difficulties</li>
<li>Orthostatic intolerance</li>
<li>Symptoms wax and wane</li>
<li>Whole body flu-like arthralgias and myalgias, or widespread
body pain</li>
<li>The cause of CFS symptoms is unknown, but there is an
identifiable trigger in a majority of the cases that we see.</li>
</ul>
<i>Precipitating Factors and Natural History</i><br />
<ul>
<li>Symptoms develop over hours or days</li>
<li>Up to 85% report a trigger (bacterial or viral infection in
75% of cases)</li>
<li>Natural course of the illness is to wax and wane</li>
<li>Unpredictable onset and severity of symptoms, many relapses
occur spontaneously and last for an indefinite period of time, which make it
difficult for a person with CFS to plan ahead, or function on a regular,
predictable or sustained basis</li>
<li>Most adults do not return to their pre-illness level of
function, total recovery is uncommon</li>
</ul>
</div>
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<br />
Individuals with CFS are also more likely than the general
population to suffer comorbidities such as fibromyalgia, irritable bowel and
bladder, Sjogren’s, Ehlers Danlos syndrome, and several other medical
conditions. Sadly, it is an “invisible illness,” and to the casual observer
patients appear entirely normal and healthy, but the gravity of the disease is
such that it totally changes one’s lifestyle, and the lives around that patient
as well.</div>
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<br /></div>
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One of my patients pointed out to me, “This illness can take
away everything, your dignity, your livelihood, your family, your marriage, and
even all of your money.”</div>
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<br /></div>
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As you can imagine, the symptoms of chronic fatigue syndrome
overlap with many disorders, including depression, MS, systemic lupus,
endocrine disorders, hepatitis, and many other illnesses. So, in order to
confirm a diagnosis of chronic fatigue syndrome one needs to exclude disorders
that could plausibly explain the exertion intolerance and the other
symptoms. The essentials of an
evaluation include a thorough history, a thorough psychosocial history, such as
a history of dysfunctional childhood, prior verbal or physical abuse, substance
abuse, a complete physical examination, a mental health examination. Such an
evaluation typically takes about 30 minutes to 60 minutes in my office. </div>
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<br /></div>
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Lastly, it’s recommended to obtain basic screening lab
tests. They may include a CBC with differential, sed rate, urinalysis, thyroid
tests, metabolic panel, glucose, BUN, creatine, electrolytes, and other lab
tests to rule out other possible sources of fatigue such as infection,
autoimmune disorders, endocrine or hormonal problems, celiac disease, etc . The
results of these tests are usually unremarkable.</div>
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<br /></div>
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The IOM recommends making the diagnosis actively. That means
making the diagnosis promptly, even before one excludes other plausible causes.
The IOM criteria for SEID provide a brief and simple method for diagnosing CFS.
But many clinicians, including myself, corroborate the diagnosis with
established instruments such as the Fukuda criteria of 1994, or the Canadian
Consensus Criteria. </div>
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<br /></div>
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Making the diagnosis promptly reduces anxiety and
uncertainty for the patient and reduces medical costs, because numerous
exclusionary lab tests and procedures would not be needed.</div>
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<br /></div>
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Let’s consider the prognosis for these patients. In a
systemic review of the natural course of CFS, a median of 39.5% of adults with
CFS improved and a median of 5% experienced full recovery. The likelihood of
recovery decreases with baseline illness severity, duration of the illness, and
the presence of comorbid psychiatric conditions. </div>
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Children and adolescents fare somewhat better, with one
paper reporting 60% recovery at five years, and 88% at twelve years after the
onset of their illness. In another longitudinal study of 25 adolescents with
CFS compared to 25 controls, 80% of the patients had remitted over a course of
25 years, but many still reported more impairment than the controls. </div>
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<br /></div>
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The management of chronic fatigue syndrome can be briefly
summed up by these four pillars:</div>
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<br />
<ol>
<li><i>Education</i> – Reliable information should be provided to the
patients, and an excellent source is online at the CDC.gov/cfs website.</li>
<li><i>Behavioral modification</i> is effective to limit depression,
anxiety, and abnormal coping mechanisms, such as denial and escape avoidance.</li>
<li><i>Pharmacologic therapy</i> – Sleep disruption and pain are
usually addressed first, and may require consultation with a sleep specialist
or pain management group. We generally avoid narcotic medications, but helpful
therapies include tricyclics such as amitriptyline, cyclobezaprine, the NSRIs,
such as duloxetine and milnacipran, anti-epileptic medications like pregabalin.
The next step is to address severe symptoms and comorbidities that the patients
suffer.</li>
<li><i>Non- Pharmacologic therapy</i> might include Epsom soaks, hot
and cold packs, liniments, massage, osteopathic manipulation, acupuncture, and
the like. Another form of non-pharmacological therapy is staying active, but
not too active. </li>
</ol>
</div>
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We recommend starting with very low levels of activity, and
proceeding slowly. Brief intervals of activity should be followed by adequate
rest in order to avoid a flare of symptoms or to avoid the post-exertional
malaise. Consider beginning to active stretching and range of motion exercises
against gravity. Then follow with light resistance training with light weights
for example, or elastic bands. We then advance to certain types of aerobic
activities such as tai chi, yoga, walking, bicycling, or aqua therapy. To avoid
flares, patients should limit activity by time, say less than five minutes per
day to start, and limit the number of repetitions, and if they experience any
excessive fatigue, reduce the amount of time, or the number of repetitions. <br />
<br /></div>
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In summary, we can find chronic fatigue syndrome in both
pediatric and adult groups. It typically has a preceding medical event, often
infection. Patients benefit from earlier comprehensive evaluation and
diagnosis. The disease can have a severe
impact on quality of life, but improvement and recovery are certainly possible.
There is no curative therapy, but graded exercise and some types of </div>
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pharmacotherapy can be of great benefit. Thank you.<br />
<br />
____________________</div>
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<b>Beth Unger</b> [17:42]: When designing a public health approach to
illness, one of the first steps is to understand the epidemiology of the
condition. For CFS the answer to this question is difficult because there is no
simple test to make the diagnosis, and findings will differ depending on how
the patients are identified. For example, self-report compared with clinical
assessment, as well as where the study is conducted. For example, in clinics
compared with the population as a whole. Population-based studies that include
clinical assessments are generally considered to give the most accurate
estimates. But these are complex and expensive. Extrapolating estimates from
three U.S. population-based surveys to the country as a whole, we can estimate
that at least one million Americans suffer from CFS. Most patients identified
in the population surveys have been ill longer than five years, and only about
half of those affected continue to seek medical care.</div>
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In addition, only about 20% of those identified as CFS have
been actually diagnosed by a physician. This emphasizes the need for more
physician education about this illness. </div>
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These studies indicate that CFS is three to four more times
more common in women than in men. Persons of all race and ethnic backgrounds
are affected, and there is a disproportionate burden of CFS in minority and
socioeconomically disadvantaged groups. </div>
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The highest incidence of prevalence is in 40-50 year olds,
but the age range is broad and includes children and adolescents. </div>
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It’s important to understand the economic impact of the
illness and barriers to healthcare utilization. Patients, their families, and
society all bear significant costs associated with CFS. These include direct medical costs of
provider visits and medications, and indirect costs of lost productivity. </div>
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In the U.S., the estimated annual cost of direct costs is
between nine and fourteen billion dollars. And nearly one-quarter of these
expenses is paid directly by the patients and their families. </div>
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The estimated annual cost of lost productivity is between
nine and thirty-seven billion dollars. </div>
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When CFS occurs before age 25, the ability of patients to
complete their education is significantly impaired. Inability to achieve their
full education potential can have a lifelong impact on earning potential. </div>
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CFS patients face significant barriers to receiving
appropriate healthcare. A population-based study in Georgia found that 55% of
persons with CFS reported at least one barrier to healthcare. Finances
prevented 10% from seeking care. This is twofold higher than the population
average found in the 2005 national health interview survey. </div>
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While the cause or causes of CFS are unknown, studies have
identified some factors that are associated with the illness. Risk factors may
suggest avenues to explore to discover causes, or to develop interventions.
Infections have been linked to CFS because patients often report an acute onset
after a flu-like illness that does not go away. And some patients have a
history of frequent infections prior to their illness. Epidemiologic studies do
not support association with any single pathogen. </div>
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<br /></div>
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Post-infectious fatigue, that is, failure to recover from a
documented infection occurs in about 10% of patients with a variety of viral
and non-viral pathogens, such as Epstein-Barr virus, Ross River virus, Q fever (that is Coxiella burnetii), or giardia. </div>
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The severity of the acute infection is most predictive of
subsequent illness, and there is no evidence of an unusual persistence of
infections in those who remain ill. </div>
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Compared to healthy controls, persons with CFS had more
exposure to significantly more stressors and are likely to have a higher
allostatic load, that is, a measure of the physiologic consequences of chronic
neuroendocrine response to stress. They are also more likely to have metabolic syndrome.
</div>
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These associations are unlikely to be specific to CFS, as
stress is a factor in many chronic illnesses. </div>
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Twin and family studies support the contribution of both
genetic and environmental factors in CFS. No specific genes have been
identified, and a polygenetic explanation for increased susceptibility is most
likely. </div>
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CDC recently shifted its focus from population-based surveys
to studying CFS patients being cared for by clinicians with specialized
expertise in CFS. Population-based surveys are helpful to identify the full
spectrum of those affected and include a broad range of illness severity.
Patients identified from clinics tend to have more severe illness. Most studies
of CFS have been conducted in patients enrolled from single clinics and include
small numbers of patients. Many intriguing findings have not been replicated,
leading to the suggestion that heterogeneity of patients may contribute to this
difficulty.</div>
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Our study is designed to document a comprehensive picture of
CFS patients in multiple clinics, and to describe the approach that experts use
to diagnose and manage their patients. We use standardized questionnaires to
measure the major domains or characteristics of the illness. These
questionnaires measure the level of function, pain, fatigue, type of severity
of symptoms, and sleep.</div>
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We also collected medical history, family history, physical
examination results, medications, and results of laboratory tests. We included
the PROMIS instruments that were designed and validated by NIH to measure
symptoms experienced in many different illnesses to allow comparison between
illnesses. The SF 36 measures of function and multi-dimension fatigue inventory
have also been widely used in a variety of conditions. Seven clinical sites
have participated in this study, which was initiated in 2011. Five participate
under the umbrella organization of the Open Medicine Institute Consortium. The
clinicians participating are all well-known, respected experts in CFS and
include one of our speakers today, Dr. Lapp. Their expertise is what gives
credibility to the study.</div>
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We are very grateful to their patients who have agreed to be
part of this study and have accepted the additional burden of completing the
many questionnaires required. </div>
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We collected complete data of 471 patients in the baseline
study. These were distributed fairly evenly across the clinics. The mean
patient age was 48.2 years and the mean duration of illness was 14.3 years.
Most patients were female and the vast majority were white. The mean BMI was
26.6. More than three-fourths of the patients had a college education and
nearly all were insured.</div>
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While about three-fourths were unemployed, only 14% were
receiving unemployment benefits.</div>
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There were statistical differences in the demographics
between all the clinics in these measures, except the proportion not working. </div>
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The patients in these specialty clinics may not be
representative of CFS patients in other healthcare settings, as they were all
highly educated and with sufficient socioeconomic support to be able to
navigate their way to these specialized centers. Most patients had been seen
and evaluated by more than one physician prior to coming to their clinic. </div>
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<br />
We found significant heterogeneity in the patients overall,
but there were very few differences between clinics in these average
measures. [Slide] The important feature
to note is that the patients show significant functional impairment,
particularly for vitality and physical functioning, but there is a relative
preservation mental health and role emotional.</div>
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The data in our study confirms the seriousness of this
illness and the extent of impairment experienced by patients with CFS. We are
continuing this study to collect longitudinal measures of illness
characteristics and to enroll groups of patients that have been understudied,
specifically pediatrics, severely ill or homebound patients, and patients
within two years of onset of the illness. We are also enrolling healthy
controls and ill comparison groups who may present similarly to CFS. In
addition we are collecting blood and saliva on those enrolled so that they can
be tested for biomarkers that have shown promise in smaller studies.</div>
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Results from this study will help to find patient subgroups
that reflect different causes or that could suggest targeted therapies. </div>
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Finally, the data clearly show that the patients in these
specialty clinics are highly educated with significant financial and social
support that enable them to reach these expert physicians. Again, this emphasizes the need for
dissemination of knowledge about CFS to the broader medical community.</div>
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It is clear that despite decades of work, CFS remains a
challenge for clinicians. Patients have difficulty finding a compassionate and
appropriate care. Physicians and other healthcare workers need evidence-based
information about CFS. CDC has responded to this need by developing a series of
continuing medical courses. In 2012 and 2013 we partnered with Medscape to
present two roundtable discussions that were targeted to primary care
physicians. These reached more than 22,000 physicians and more than 6,000
continuing medical education credits were issued. Currently, CDC has two free
online courses available on the CFS website. These are accredited for
physicians, nurses, and other healthcare professionals. </div>
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However, CFS is rarely covered in medical schools, and this
leaves a vacuum of knowledge. So we’ve begun the process of developing
standardized patient videos accompanied by educational curriculum for the MedEdPORTAL.
</div>
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<br /></div>
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This is a free online service provided by the Association of
American Medic al Colleges. The materials are peer-reviewed and once approved
are made available to medical school faculty free of charge. </div>
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<br /></div>
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Finally, CDC is continuing communication with the general
public and advocacy community. An important part of this has been the
introduction of patient-centered outreach and communication calls (PCOCA
calls). These are one-hour teleconferences that are available toll-free in the
U.S. They began in 2012 and are generally held twice a year. The format is that
the CDC uses the first ten minutes to give an update on current activities of
the CFS program, and then an outside expert or group of experts presents
information on a topic of interest to the community. These talks generally last
35 to 40 minutes and are followed by answers to questions submitted to the
PCOCA email. Topics have included identifying patients for clinical studies,
exercise, infection and immunity in CFS, CFS and cognitive function, sleep research
and CFS, Stanford’s research program, and self-management strategies in CFS. </div>
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<br /></div>
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We are grateful to all the experts who graciously gave up
their time to share their insights with the patients and their families. </div>
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<br /></div>
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Most recently, we’ve begun a new initiative to include broad
stakeholder collaboration into developing educational materials. Including the
viewpoints of patients, medical professional organizations, medical educational
organizations, expert clinicians and government agencies will help assure the
quality and usefulness of these products, and help facilitate dissemination in
the medical community at large. </div>
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<br /></div>
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Our first focus will be modification of the CDC CFS web page
to incorporate recommendations of the Institute of Medicine. I’d now like to turn
the podium to Dr. Komaroff.<br />
<br />
____________________</div>
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<b>Dr. Anthony Komaroff</b>
[31:07]: I was asked to speak about three recent authoritative reports , in
which experts, many of them from outside the field of chronic fatigue syndrome
evaluated the evidence that’s been published. </div>
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The first is from the Institute of Medicine of the National
Academies of Science, which issued a 300-page report in which the panel
reviewed the literature of nearly 9,000 published articles, and concluded that
ME/CFS is a biologically based illness, and proposed a new case definition as
well as a new name. </div>
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The second report was from the NIH, which held a Pathways to
Prevention conference with a follow-up report drawing similar conclusions about
the biology of ME/CFS. </div>
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Finally, the federal Agency for Healthcare Research and
Quality (AHRQ) commissioned an independent review that focused on diagnosis and
treatment. </div>
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The Institute of Medicine report first addressed the
question of the scope and seriousness of ME/CFS, drawing heavily I might say on
published studies from the CDC. The Institute concluded that between 800,000
and 2.5 million Americans have the illness. The Institute also agreed that the
costs of the illness to society were substantial, as much as 51 billion dollars
annually.</div>
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Based on their review the Institute panel concluded that
“ME/CFS is a serious, chronic, systemic disease that often can profoundly
affect the lives of patients” and that ME/CFS is not, as many physicians
believe, a psychological disorder.</div>
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Then the Institute turned to an important question: Given
that ME/CFS is defined exclusively by subjective symptoms, symptoms that any
human being can say they have, are there any confirmatory, underlying objective
biological abnormalities in these patients compared to healthy subjects and
compared to patients with other fatiguing illnesses? That includes comparison
with the biological abnormalities in some psychiatric illnesses.</div>
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The Institute of Medicine found considerable evidence of
underlying neurological abnormalities as reflected by many different diagnostic
technologies. Those singled out for special mention by the panel included
slowed information processing, problems with white matter integrity,
neuroinflammation, impairment of working memory, HPA axis abnormalities, and
autonomic abnormalities. The NIH report was in general agreement with the
Institute on this issue. </div>
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The Institute of Medicine also concluded that there were
considerable immunologic abnormalities in patients with ME/CFS. They
highlighted two as being particularly well substantiated: impaired natural cell
killer cell function that correlated with illness severity, and increased
cytokine levels in blood, suggesting a state of chronic immune activation. The
Institute of Medicine noted that many, but not all patients, with ME/CFS
reported that their illness began following an acute infectious-like illness
characterized by fever, myalgias, respiratory, GI, neurologic symptoms, along
with severe fatigue, an illness from which patients say they have never
recovered.</div>
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Indeed, the medical literature includes many reports of
post-infectious fatigue syndromes linked to well-documented acute infections.
For this reason many have wondered if at least some cases of CFS may be
initiated or even perpetuated by infection. The Institute panel concluded that
there is “Sufficient evidence suggesting that ME/CFS follows infection with
Epstein-Barr virus and possibly other specific infections, viral, bacterial,
and possibly protozoal.” </div>
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NIH report concurred in this and called specifically for
research on the possible role of herpes viruses in ME/CFS. </div>
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There have been several case definitions proposed for this
illness. Perhaps the most widely used is the case definition developed under
the leadership of the CDC and published in 1994. The Institute of Medicine
panel proposed a new case definition that it hoped would be simpler and
shorter, easier to apply consistently across patients, likely to result in
fewer false negative and false positive classifications, and likely to be a
better predictor both of response to therapy as well as prognosis. </div>
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The key elements of the proposed new case definition by the
Institute are: 1) Post-exertional malaise, defined as a prolonged worsening of
a patients’ baseline symptoms after physical or cognitive exertion, or
orthostatic challenge, exertion, or stress, 2) Unrefreshing sleep, defined as
regularly feeling unrefreshed after sleeping many hours, 3) Cognitive
impairments of a side variety of types that are made worse by exertion, effort,
stress, or time pressure, and 4) Orthostatic intolerance, or symptoms that
worsen upon assuming and maintaining and erect posture and that are improved by
lying down or elevating the feet. [Slide]<br />
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The IOM case definition is shorter, but it is not simple.
But at the moment I think it is the best we can do.</div>
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The new case definition, like most that preceded it, does
not include laboratory studies. ME/CFS remains a multi-system disease for which
we do not yet have a single diagnostic biomarker. Indeed, until there is a gold
standard pathological finding for the illness, I don’t think it will be
possible to test the accuracy of any case definition. It will, however, be
possible to compare the performance of different alternative case definitions
against each other in large numbers of patients, and that already is underway.
As pointed out by the AHRQ, a new case definition does need to be tested
empirically to verify that it is superior to its predecessors.</div>
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The name chronic fatigue syndrome was coined in 1988 by a
group convened by CDC. As a member of that group, I would note that we were all
focused on developing a case definition. No one really thought about the name,
and when someone proposed the name chronic fatigue syndrome, people said “Why
not?” That was a big mistake.</div>
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Many of the patients and clinicians believe that that name,
chronic fatigue syndrome, trivializes and stigmatizes this often devastating
illness, and I certainly agree.</div>
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Many different names have been proposed. The new name
proposed by the Institute of Medicine, Systemic Exertional [sic] Intolerance
Disease [<i>note: SEID stands for Systemic
Exertion Intolerance Disease</i>], has some merits. It focuses on a core component of the
illness. But I think it’s too early to determine whether this new name is going
to be widely adopted by both the clinician and patient community. </div>
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In summary, the Institute of Medicine and the NIH reports
conclude that patients with ME/CFS have underlying objective biological abnormalities,
that their symptoms are not imaginary. However, none of these biologic
abnormalities is so sensitive and specific that it constitutes a biomarker, a
diagnostic test. </div>
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ME/CFS is an important disease causing great suffering to
many individuals and their families, and billions of dollars in lost
productivity to society. Finally, more research is urgently needed and indeed
the NIH along with CDC has recently announced its intention to expand its focus
on this illness, particularly in its intramural program as described next by
Dr. Avi Nath.</div>
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<i>END PART I</i></div>
Erica Verrillohttp://www.blogger.com/profile/10203906377475992984noreply@blogger.com